Our Culture

Fairness, respect and inclusion sit at the core of our name. Our people are our greatest asset, so we are continually investing in our people, process improvement and technology to deliver the very best to our customers. As an organization, we are committed to inclusion, we own our limitations, and we value new and different ideas.

Eight Signs of a Strong Company Culture

Diversity & Inclusion

Meitheal is passionate about inspiring and maintaining diversity and inclusion in the workplace. Companies that embrace people for their talents and character regardless of age, gender identity, race, sexual orientation, physical or mental ability, ethnicity, and perspective are simply better places of business.

More important, creating an environment where everyone from any background can do their best work isn’t just the right thing to do: It is the smart thing to do.

Equal Opportunity

Meitheal provides equal opportunity employment to all employees and applicants for employment.

We further prohibit discrimination and harassment of any type at work without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Our equal opportunity employment policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Community Meitheal

What do today’s employees really look for in a company, and what are the best ways a business gives back? At Meitheal, those are questions we think about often – and strive to answer in the most meaningful ways.

We understand that today’s dedicated professionals in generics, specialty biopharma and fertility desire qualities such as a good match of skills and position; opportunities to further learn and develop; an inspiring, progressive environment; and a culture of inclusion and diversity.

They also truly want to be a part of something greater – something that gives back and sustains. Meitheal shows its commitment to the community through various employee volunteer opportunities, fundraising, and partnerships with local non-profits.

Just a few of our specific community efforts include:

  • Tutors and board members of Tutoring Chicago, which tutors children of the city and Chicago Public Schools
  • Donors and volunteers for the Greater Chicago Food Bank and the Lakeview Pantry
  • Salvation Army Christmas Giving Tree, providing Christmas presents for children in foster care
  • Feed My Starving Children, packing and shipping meals for developing countries
  • Rosemont Operation North Pole, providing a Christmas experience for terminally ill children who are health-compromised and their families
  • Active partnerships with the Direct Relief Agency, donating our drug products throughout the year during times of crisis or need

Our Benefits

We strive to offer a robust benefits program that meets the needs of each of our team members.
Just a few of the many benefits we offer include:

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Extensive Health
Offerings Including
Medical, Dental, Vision

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Paid Time Off (PTO)

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Company Paid
Holidays

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Onsite Gym
Membership

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401K Retirement
Savings Plan

Benefit icon

Annual
Performance-Bonus
Opportunity

Benefit icon

Short- and Long-Term Disability

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Paid Parental
Leave

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Employee Wellness
Resources

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Flexible Work
Arrangements

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Competitive
Wages

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Life and AD&D
Insurance

Have questions?

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More info

Careers

We love to empower the careers of those who are committed, curious, collaborative, and courageous.

At Meitheal, we are united by our mission to provide easy access to fairly priced products. Meaningful work creates a meaningful career. With this, we provide the opportunity to not only improve the quality of life for patients, but for you to grow professionally as well. We embrace the diversity of our employee culture and the contributions that come from this.

By providing insightful guidance and fostering an environment of empowerment and collaboration, we celebrate our successes together. Our award-winning culture and exceptional team give us much to be proud of.

We are growing rapidly, so check back often!

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Learn more about who we are and what we do at www.meithealpharma.com.


Position Summary:

The Account Manager - Generic Pharmaceuticals will be responsible for consistently meeting and exceeding territory sales and performance targets for the Generics pharmaceutical portfolio through virtual customer interactions that include Integrated Delivery Networks (IDNs) and regional key customer(s) in acute hospital, and acute, non-hospital facilities. This role reports to the Director of Sales and Commercial Effectiveness and will work closely with National Accounts, Marketing, Contracting, and other internal departments to meet agreed upon goals and objectives. This is a remote, field-based sales position with some travel as required.


Account Manager, Northeast covers the following states: CT, DE, MA, ME, MD, NH, NJ, NY, PA, RI


Compensation for this role is $88,000 to $120,000 (Bonus Eligible). Payrate is determined by considering a person's prior experience and competence.  


The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Essential Duties and Responsibilities

  • Effectively generate product demand by educating and engaging customers through the promotion of the Generics pharmaceutical portfolio.
  • Proactively identify business opportunities and present value propositions aligned to customer needs and objectives.
  • Establish and deepen relationships with key decision makers and influencers within assigned organizations.
  • Function independently, with a high degree of sales proficiency, to drive sales performance and ensure sales forecasts and assigned budgets meet or exceed territory expectations.
  • Identify and drive opportunities with assigned customers, and develop strategies to gain and increase sales, product share, revenue, and profit through compliance to GPO, Individual and Company-based agreements.
  • Develop and execute product pull-through strategies that increase adoption and usage of Meitheal products.
  • Develop, execute, and monitor territory and business plans; strategically and consistently targeting key stakeholders within each account to expand product usage and customer base.
  • Conduct customer calls and meetings to drive contract compliance, discover unmet opportunities and position the Company’s future products.
  • Advance customers along the sales continuum and gain product usage commitment through effective questioning, active listening, contract negotiation, objection handling, and utilizing approved marketing and sales materials.

·        Provide market intelligence to internal teams as received, and as requested.

  • Achieve success in a matrixed selling environment in which the need for collaboration and cross-functional discipline is critical. Cross-functional partners may consist of National Accounts, Marketing, Contract Marketing, Commercial Analytics, and Operations colleagues.
  • Use data tools and insights, and other informational sources, to determine strategies and tactics for business decision-making.
  • Utilize CRM technology in an accurate and timely manner to report activities, account level details, and pipeline opportunity management.
  • Ensure compliance with all company policies, procedures, principles, values, and applicable laws.
  • Comply with all company training requirements, learning modules, required acknowledgements (IC plans, Compliance, etc.).
  • Complete all training and administrative duties, successfully and on time. This includes, but is not limited to: accurate and complete call reporting, expense report management, time off management, etc.
  • Travel as required, to support customer and commercial team meetings.
  • Other duties may be assigned.


Competencies

  • Business Acumen
  • Communication Skills
  • Analytical Skills
  • Negotiation Skills
  • Critical Thinking Skills

Qualifications

  • Bachelor’s Degree, or equivalent combination of skills and experience required.
  • 2+ years of pharmaceutical sales experience with a minimum of 1+ year of sales experience within the acute hospital setting. Prior experience working with major IDNs and Regional Key Customers preferred.
  • Knowledge of Generic injectable drugs and prior experience promoting newly launched products.
  • Measurable track record of sales performance which includes meeting or exceeding territory performance goals.
  • Account-based selling experience, within assigned territory.
  • Strong presentation, organization, contract negotiation, administrative and communication skills.
  • Experience in utilizing and optimizing CRM systems in support of territory dynamics.
  • Demonstrated experience delivering virtual customer engagement meetings, routinely promoting and presenting product promotional materials and customer data analytics.
  • Demonstrated effective time management, organizational and communication skills to prioritize opportunities and execute flawlessly.
  • Demonstrated judgment and decision-making capability.


Computer Skills

Microsoft Office, CRM Experience, Tableau

Physical Demands

Travel

·        Some travel may be required with some variation based upon the time of year and   demands of the business imperatives. The travel requirements will vary based on the geography and account responsibilities for this position.

Work Environment

This is a field-based role.

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Position Summary:

The Associate Director of Alliance Management will manage the international generic, biosimilar and/or branded pharmaceutical partnerships to bring products to the U.S. market. This position is responsible for executing new product launches in the U.S. market, managing post approval product changes and overall product lifecycle management. The successful candidate will develop and grow internal and external global cross-functional relationships with Meitheal's manufacturing sites and partners and manage product launches from pre-development to commercialization and throughout the product life cycle. The candidate should have diverse knowledge and/or background in production forecasting/planning, product development, regulatory, quality, product launch execution/strategy, and project management. The role leads cross-functional internal and external international teams to develop generic pharmaceutical products, meet launch goals, achieve and maintain consistent commercial supply, mitigate program risks and develop and execute budgets. This role also interacts with all levels of the company reporting on launch status and life cycle management. It will interact with all corporate levels from project teams to executive management.


The compensation range for this position is $125,000 to $145,000.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.


Why Work with Us?

·        Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.

·        Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

·        Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

·        Professional Growth: We offer ample opportunities for professional development and career advancement.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.



• Leads/manages cross-functional product launch teams to bring new generic pharmaceutical products to the U.S. market on time.

• Manages and executes post approval changes during product lifecycle by coordinating with global cross functional teams and meet implementation goals.     

• Organizes, schedules, and facilitates global cross-functional team meetings to drive project’s progress, identify risks, contingency plan, and ensure commercial production and launch forecasts are being met.

• Works with Supply Chain and Sales team to develop, monitor and support product supply in accordance with sales forecast needs.

• Works closely with QA, regulatory affairs, project management and external global cross functional teams to meet launch and post approval change implementation goals.

• Manages relationship with alliance partners and contractual obligations of alliance programs.

• Creates/ and manages project milestones, develops recommendations and brings forward key decisions and/or risks to Executive Management in support of project and business objectives.                                                 

 • Manages meeting logistics to include scheduling, issuing agendas, meeting material preparation, action item identification, and writing meeting minutes.   

•  For all assigned projects, proactively identify and resolve conflicts as needed, or raises conflicts and disputes to appropriate management for timely resolution.   

•  On a day-to-day basis, work closely with functional groups such as Marketing, Supply Chain, Procurement, Finance, Regulatory, Product Development, and Quality.

Supervisory Responsibilities

None

Competencies

  • Understanding generic product launch and post approval change execution, production forecasting/planning, GMP and/or generic, biosimilar and/or branded pharmaceutical regulatory affairs.
  • • Experience in planning and managing the global cross functional aspects of generic, biosimilar and/or branded pharmaceutical launch and product lifecycle management.
  • • Demonstrated knowledge and application of Project Management tools, such as Risk Management.
  • • A high level of commitment, flexibility and independence with strong skills for planning, coordination, teamwork, communication and interpersonal relations.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

 

• Demonstrated experience in product launch execution, project management or related field.

• Detail focused with exceptional organizational skills.

• Proven ability to show initiative and sense of urgency.

 

Education and/or Experience Required

• Minimum of 7 years of relevant pharmaceutical industry experience.

• BS Degree or equivalent experience in a related field.

Education and/or Experience Required

Computer Skills

MS Office proficiency (Excel, Word, PowerPoint)

Physical Demands

Up to 15% domestic and/or international travel.

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Position Summary:

The Director of Quality Operations, position provides oversight for Meitheal’s Quality Operation processes including Complaint Investigations, Risk Management, Market Actions (e.g., Field Alerts, Medical Device Report, and Biologics Product Deviation Report, Recalls and Annual Product Quality Reviews. This position ensures Meitheal maintains a state of compliance for Meitheal’s Quality Programs. This position leads or actively participates in implementation of updates and enhancements to these processes including monitoring emerging or changing regulations related to pharmaceuticals, biologics, and combination products and applying them as necessary. Oversee the intake, processing and review of Product Complaints and Inquiries. Collaborates with Meitheal's Pharmacovigilance department, as needed. Manages mock recall process and manages/participates in market actions or product recalls, as needed. Leads Continuous improvement efforts and Risk management, as applicable. 


The salary range for this position is $188,000 to $220,000.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.


Why Work with Us?

·        Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.

·        Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

·        Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

·        Professional Growth: We offer ample opportunities for professional development and career advancement.

 

Essential Duties and Responsibilities

·        Lead, direct, oversee and mentor direct reports and their respective functions.

·        Manage and oversee product quality complaint and inquiry intake and processing.

·        Review and approve product quality complaint investigations.

·        Provide Product Complaint Coordination and oversight for Multiple Suppliers for Branded Products.

·        Manage and oversee the Annual Product Quality Review (APQR) process.

·        Review and approve APQR Reports.

·        Participates in authoring, collaborating and approval of Quality risk assessments.

·        Serves as the in-house Risk Management operations expert.

·        Responsible for preparation of Market Actions in collaboration with manufacturing partners, as needed.

·        Support management with Recall Committee meetings.

·        Conduct Mock Recalls in accordance with Meitheal’s procedures.

·        Responsible for Recall activities, as needed.

·        Lead and direct continuous improvement projects for applicable functions, as needed.

·        Provide support to other areas within Quality, as needed.

·        Remain current in regulatory trends and requirements.

Supervisory Responsibilities

Supervisory responsibilities including one or more direct reports.

Competencies

·       Business Acumen

·        Judgement

·        Change Management

·        Project Management

·        Ethics

·        Interpersonal

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

 

• Assimilates to changing environments.

• Ability to prioritize and multitask.

• Organized and detailed orientated.

• Strong written and communication skills.

• Has a sense of urgency to meet all required deadlines.

• Knowledge of CGMP and GDP as well as FDA trends and guidelines.

• Strong interpersonal skills required.

• Elevates issues to management, when appropriate.

Education and/or Experience Required

Bachelor's degree; 12+ years of progressive, challenging QA experience in the pharmaceutical industry; excellent knowledge of current GMP as well as FDA trends and guidelines; strong interpersonal skills and great attention to detail; background in aseptic processing, preferably with injectables, and experience with complex generics, drug-device combination productions, biosimilars, or biologics is a plus.

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Position Summary:

The Senior Director Sales Operations is responsible for leading and optimizing the sales operations function to drive efficiency, effectiveness, and productivity within the commercial sales, marketing, and virtual sales teams. This role involves strategic planning, process improvement, data analysis, a focus on optimization, and cross-functional collaboration to support the achievement of sales targets and business growth. The Senior Director, Sales Operations, will manage a team working with sales commission plans, territory design, and operational projects.

 

The compensation range for this position is $185,000 - $235,000.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.


Why Work with Us?

· Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.

· Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

· Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

· Professional Growth: We offer ample opportunities for professional development and career advancement.

Essential Duties and Responsibilities

· Strategic Planning and Execution:

· Develop and implement sales operations strategies (e.g., sample management, sales territory design, sales incentive design and implementation, commercial workforce optimization) that align with overall business objectives.

· In collaboration with senior leadership, define and implement operational projects which help achieve sales goals and deliver revenue.

· Sales Process Optimization:

· Analyze and refine sales processes to improve efficiency and effectiveness.

· Implement best practices and tools to streamline sales activities and enhance productivity.

· Define and improve sales force effectiveness metrics.

· Assess and develop sales operations training, as required.

· Sales Incentive Compensation Leadership

· Lead the development, administration, budgeting, and effectiveness of sales incentive compensation plans.

· Carefully develop and manage sales incentive compensation budgets in partnership with commercial finance.

· Lead the development and communication of sales incentive compensation.

· Develop and implement incentive compensation governance programs.

· Sales Data Analysis and Reporting:

· Oversee the collection, analysis, and reporting of sales data to provide insights and recommendations.

· Work cross-functionally to develop and maintain dashboards and reports to track key performance indicators (KPIs) and sales metrics.

· Cross-Functional Collaboration:

· Work closely with marketing, finance, product, and customer success teams to ensure alignment and support for sales initiatives.

· Facilitate communication and collaboration between sales and other departments.

· Technology and Tools Management:

· Evaluate, implement, and manage sales technology and tools, such as CRM systems (Veeva), reporting systems, and related data structures to support sales operations.

· Ensure the effective use of technology to enhance sales processes and data management.

· Budget Management:

· Develop and manage the sales operations budget, ensuring efficient allocation of resources.

· Monitor expenses and optimize costs to achieve financial targets.

· Contract compliance:

· Develops and manages enhanced Tableau-based contract compliance tools; provides monthly reports and presents updates to senior leadership on GPO, IDN, Wholesaler and other key contract performance metrics.


Competencies

  • Business Acumen
  • Judgement
  • Change Management
  • Project Management
  • Ethics
  • Interpersonal


Qualifications

  • Bachelor’s degree in business administration, Sales, Marketing, or a related field; MBA preferred.
  • 15+ years of experience in sales operations, with at least 5 years in a leadership role.
  • Strong analytical and problem-solving skills, with the ability to interpret complex data and make data-driven decisions.
  • Excellent communication and interpersonal skills, with the ability to influence and collaborate with stakeholders at all levels.
  • Proficiency in sales technology and tools, such as CRM systems (e.g., Salesforce, PowerBI, Varicent, etc.).
  • Proven track record of driving sales process improvements and achieving sales targets.
  • Strong leadership and team management skills.


Physical Demands

  • Up to 25% occasional travel may be required.


AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Position Summary:

The Regulatory Affairs Manager (CMC) position is responsible for the author, review, preparation and manage on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC. 


The pay range for this position is: $85,000 - $115,000. 


The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.


Why Work with Us?

· Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.

· Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

· Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

· Professional Growth: We offer ample opportunities for professional development and career advancement.


Essential Duties and Responsibilities

The primary responsibility will include authoring, reviewing and preparing high quality ANDA, NDA, BLA, IND and DMF submissions.


· Prepare, review and submit responses to FDA’s CRLs, DRLs and Information Requests within predetermined and negotiated deadlines.

· Review and submit post-approval supplements, safety update reports to INDs, NDAs, ANDAs and BLAs.

· Participate in development and commercial team meetings representing RA CMC.

• Review and approve change controls from global manufacturing partners 

• Experienced with FDA’s eCTD requirements for Modules 1-5. 

• Work in a collaborative environment with cross-functional teams, not limited to Labeling, R&D, Manufacturing, Medical Affairs, Operations, Marketing and Quality.

• Adhere to submission timelines as per the internal tracking. Administration and management of assigned products. Perform other duties as assigned by the Supervisor.

• Maintains current knowledge of regulations. Serves as the primary regulatory interface with US FDA manufacturing partners (domestic and international), and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while following all regulatory requirements.

• Support Biosimilar BLA/PAS/CBE submissions, as assigned.

Competencies

  • Planning and Organizing
  • Communication
  • Strategic Thinking
  • Teamwork
  • Problem Solving
  • Quality
  • Judgement
  • Dependability

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.


• Assimilate to changing environments.

• Ability to prioritize and multitask.

• Organized and detailed orientated. 

• Have a sense of urgency to meet all required deadlines


Education and/or Experience: 


  • Bachelor's degree in life sciences from a 4-year college or university with 5 or more years of direct experience in Regulatory Affairs within bio/pharmaceutical companies, with focus in CMC. Candidates with additional prior experience in R&D or Manufacturing will be a plus.
  • Excellent attention to details, technical writing, organizational and communication skills.
  • Ability to prioritize and handle multiple projects concurrently.
  • Familiar with 21 CFR, FDA and ICH.

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Position Summary:

We are seeking an experienced and strategic legal professional to join our legal team as Senior Counsel – Intellectual Property & Transactions. This role will provide critical legal support for our growing biosimilars pipeline, oversee intellectual property strategy and portfolio management (including patents and trademarks), and manage key litigation and transactional matters. This individual will serve as a strategic advisor to leadership on IP-related risks and opportunities and will collaborate cross-functionally to help drive innovation and growth.


The compensation range for this position is $245,000 to $290,000.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.


Why Work with Us?

· Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.

· Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

· Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

· Professional Growth: We offer ample opportunities for professional development and career advancement.

Essential Duties and Responsibilities

Intellectual Property Strategy & Portfolio Management

  • Serve as the primary legal advisor on intellectual property matters, including patents, trademarks, trade secrets, and copyright issues.
  • Manage the Company’s patent and trademark portfolio, including prosecution, enforcement, licensing, and renewals.
  • Collaborate with R&D, Regulatory, and Corporate Strategy teams to assess and manage IP risks related to biosimilar and branded product development.
  • Oversee IP-related due diligence for business development opportunities, partnerships, and acquisitions.
  • Partner with external counsel on patent and trademark filings, oppositions, and portfolio strategy.

Litigation & Legal Risk Management

  • Manage and oversee patent, trademark, and Hatch-Waxman litigation, including coordination with outside counsel and internal stakeholders.
  • Develop and implement litigation strategies to defend against challenges and enforce the Company’s IP rights.
  • Stay abreast of legal developments affecting the pharmaceutical and biosimilar sectors and provide risk assessments to senior leadership.

Licensing & Transactions

  • Lead or support negotiation and drafting of complex IP-related agreements, including in-licenses, out-licenses, development collaborations, material transfer agreements, and technology agreements.
  • Provide legal guidance and transactional support on strategic partnerships and new product opportunities, particularly related to IP assets.

General Corporate and Commercial Legal Support

  • Review, draft, and negotiate a wide range of agreements across multiple business units, including Purchase Agreements, Vendor & Service Contracts, NDAs, Master Service Agreements, Quality Agreements, and Pharmacovigilance Agreements.
  • Support compliance with contract lifecycle management systems and internal contract policies and processes.
  • Provide guidance on regulatory, compliance, and advertising/promotional matters as needed, especially for biosimilars.

Cross-Functional & Internal Support

  • Partner with cross-functional teams to ensure IP and legal considerations are integrated early in product lifecycle planning.
  • Collaborate with HR on employment-related legal matters, such as policies, employment agreements, and handbook updates.
  • Contribute to the development and delivery of internal legal and compliance training.


Qualifications

  • J.D. from an accredited law school and admission to at least one U.S. state bar.
  • 12+ years of experience in a law firm and/or in-house legal department, with a focus on intellectual property, litigation, and transactional work in the pharmaceutical or biotech industry.
  • Experience managing patent and trademark portfolios, Hatch-Waxman litigation, and licensing transactions.
  • Strong understanding of biosimilars, FDA regulatory frameworks, and IP issues affecting the life sciences sector.
  • Excellent judgment, communication, and interpersonal skills.

Additional Notes:

  • This position will complement the work of the Company’s Associate Counsel, who will assume lead responsibilities for legal support of the Company’s generic pharmaceutical products and related commercial agreements.


AAP/EEO Statement

Equal Opportunity Employer:

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Summary

About Us:

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.


Position Summary:

The Sr. Regulatory Affairs Associate (CMC) position is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers with an emphasis on CMC.


The estimated salary range reflects an anticipated range for this position of $70,000 to $90,000. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.


Why Work with Us?

·       Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.

·       Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

·       Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

·       Professional Growth: We offer ample opportunities for professional development and career advancement.

Essential Duties and Responsibilities

• Supports life cycle management of approved products. Preparation and review of ANDAs, NDAs, annual reports, periodic adverse events reports, supplements, amendments, control correspondences etc.

• Reviews and management of regulatory submissions to FDA from international partners and CMOs for technical and regulatory compliance.

• Review and approve change controls from global manufacturing partners

• Familiar with FDA requirements and ICH.

• Adhere to submission timelines as per the internal tracking. Administration and management of assigned products. Perform other duties as assigned by the Supervisor.

• Maintains current knowledge of regulations Serves as the primary regulatory interface with US FDA manufacturing partners (domestic and international), and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while following all regulatory requirements.

• Support Biosimilar BLA/PAS/CBE submissions, as assigned.

 

Competencies

·      Planning and Organizing

·      Communication

·      Strategic Thinking

·      Teamwork

·      Problem Solving

·      Quality

·      Judgement

·      Dependability

 

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

 

•     Assimilate to changing environments.

•     Ability to prioritize and multitask.

•     Organized and detailed orientated.

•     Have a sense of urgency to meet all required deadlines.

  

Education and/or Experience Required

Education and/or Experience:

·      Bachelor’s degree in life sciences preferred, or equivalent experience required

·       5 or more years of recent pharma / biotech / life sciences industry experience in a related function (Regulatory Affairs, R&D, Quality, Manufacturing) preferred

·       Strong written and communication skills.

·       Ability to handle multiple projects concurrently

·       Familiar with 21 CFR, FDA and ICH.

 

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

Summary

ABOUT MEITHEAL PHARMACEUTICALS

Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectables and, as of 2022, has expanded its focus to include fertility, biologics, and biosimilars. Meitheal currently markets 50 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytic, intensive care, and fertility. As of the end of April 2023, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 21 products planned for launch in 2023, and an additional 20 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked among the top 100 Crain’s Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for — Meitheal (Mee·hall): working together toward a common goal, for the greater good.

The Senior Director, Quality will provide strategic and operational leadership for Meitheal Pharmaceuticals’ Quality Management System (QMS) across generics, biologics, biosimilars, and device programs. This position will oversee quality operations, partner quality oversight, inspection readiness, and continuous improvement initiatives to ensure compliance with regulatory requirements.

 

The Senior Director will work cross-functionally with Regulatory Affairs, Operations, Pharmacovigilance, and Commercial teams to drive inspection readiness, product launch quality, and global partner alignment. The role requires a balance of strategic leadership and hands-on operational execution to support Meitheal’s evolution from a generics-based organization to a biologic and biosimilars enterprise.


The salary range for this position is $220,000 to $270,000.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.


Why Work with Us?

·        Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.

·        Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.

·        Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.

·        Professional Growth: We offer ample opportunities for professional development and career advancement.


Essential Duties and Responsibilities

Quality Management System (QMS) Leadership

·        Lead the continued development and implementation of a fit-for-purpose QMS that supports generics, biologics, biosimilars, and devices.

·        Ensure all QMS elements (change control, deviation, CAPA, training, document control, complaint handling, and batch disposition) are implemented, compliant, and continuously improved.

·        Drive QMS remediation and sustainment activities based on internal audits and gap assessments.

 

Inspection Readiness & Compliance

·        Lead the development and execution of Meitheal’s inspection readiness strategy, ensuring continuous compliance with FDA, ICH, and international standards.

·        Oversee preparation and coordination of regulatory inspections, mock audits, and partner audits.

·        Serve as a key contact for regulatory agencies during inspections and audits.

 

Partner & Supplier Quality Oversight

·        Provide oversight of all contract manufacturing organizations (CMOs), testing laboratories, and suppliers to ensure compliance with cGMP and Quality Agreements.

·        Establish and maintain governance structures, KPIs, and performance monitoring for key partners (NKF, Kindos, and other affiliates).

·        Lead resolution of quality issues, CAPAs, and audit findings in collaboration with partners.

 

Quality Operations & Product Support

·        Support change control, complaint handling, and annual product quality reviews (APQRs).

·        Support product launch readiness, ensuring quality documentation, packaging validation, and stability data are in place.

·        Provide quality leadership for lifecycle management and post-market quality programs.

 

Digital Quality & Data Governance

·        Support digital QMS initiatives including TrackWise Digital, ValGenesis, and other validated systems.

·        Drive data integrity, audit trail management, and computerized system compliance per 21 CFR Part 11 and Annex 11.

·        Collaborate with IT and business functions to enhance data governance and analytics.

 

Leadership & Culture

·        Lead, mentor, and develop the Quality Systems and Compliance teams to build technical expertise, accountability, and engagement.

·        Foster a proactive, solution-oriented, and collaborative Quality culture across the organization.

·        Represent Quality in cross-functional governance committees and decision-making forums.

 

Supervisory Responsibilities

This position manages employees and is responsible for the performance management and hiring of the employees.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

 

·        Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Company’s culture and core values – courageousness, creativity, selflessness and humor.

·        Strategic thinker with the ability to execute operationally.

·        Excellent communicator and collaborator with strong analytical and problem-solving skills.

·        Demonstrated ability to lead cross-functional initiatives in a matrixed, global environment.

·        Influence and effect change within the organization.

·        Demonstrate excellent written and verbal communication skills.

 


Education and/or Experience Required

Education and/or Experience

·        Minimum of a bachelor’s degree in a scientific discipline; advanced degree preferred.

·        Minimum 15 years in pharmaceutical or biotechnology Quality Assurance.

·        Minimum 7 years in a leadership role with demonstrated success managing quality systems and partner oversight.

·        Experience with biologics/biosimilars and combination products strongly preferred.

·        Prior experience with virtual or outsourced manufacturing models (CMOs, CTLs, 3PLs).

·        Proven record of success during FDA inspections.

·        Strong knowledge of 21 CFR Parts 210, 211, 600–680, 820, and ICH Q7–Q12.

·        Understanding of data integrity, Annex 11, and GAMP 5 principles.

·        Hands-on experience with TrackWise Digital, or similar systems.

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.

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