Summary

About Us: 

Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a trailblazing company committed to the development and commercialization of generic injectables. Recently, we've expanded into fertility, biologics and biosimilars, now marketing over 50 FDA-approved products across various therapeutic areas. We embody the Irish principle of "Meitheal," fostering teamwork toward common goals, ensuring accessibility and affordability for all. 

Job Summary:

The Associate Counsel will support the Legal Department in various commercial and corporate matters, helping multiple business units including Sales, National Accounts, Marketing, Regulatory, Quality, Operations, Corporate Strategy, and Human Resources. This role will report to the General Counsel or other Senior Counsel.

Why Work with Us?

• Hybrid Work Schedule: Enjoy the flexibility to work remotely two days a week, balancing your professional and personal life.
• 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

• Review, draft, and negotiate various types of agreements (Service Contracts, Vendor Contracts, NDAs, Product Purchase Agreements, etc.).
• Provide legal guidance on regulatory, contractual, and operational matters, including interpreting and implementing legislation, regulations, and rules.
• Support the Company’s contract management system and advise internal clients on contract policies and practices.
• Assist HR with in-house legal matters, including the revision of Employee Handbook, Company policies, and Employment Agreements.
• Support Corporate Strategy with advertising and promotional materials, including website content and social media posts.
• Collaborate with other legal team members on state licensing and government compliance efforts.
• Identify the need for and create new or improved contract templates for common transactions.
• Prepare and deliver training, written guidance, and other learning aids for employees.
• Work cross-functionally with internal teams to track and maintain legal updates on the Company’s pharmaceutical products portfolio.
• Develop innovative ways to communicate effectively with the organization to achieve compliance goals.
• Enhance legal department analytics and reporting capabilities.
• Provide support to General Counsel and other Counsel as needed.

Qualifications

• JD from an ABA-accredited law school and licensed/eligible to practice in-house in Illinois.
• Minimum of 3 years of experience in a major law firm and/or the legal function of a major corporation.
• Practical experience in drafting and negotiating contractual agreements.
• Excellent analytical, drafting, negotiating, communication, and relational skills.
• Strong problem-solving, decision-making, and conceptual thinking skills.
• Ability to prioritize workload, manage projects, and meet strict deadlines.
• Knowledge of the pharmaceutical industry, including generics and biopharma, is preferred.
• Understanding FDA regulations and other laws impacting the pharmaceutical industry is a plus.

Education and/or Experience Required

Required:

•  JD from an ABA-accredited law school and licensed/eligible to practice in-house in Illinois.
• Minimum of 3 years of experience in a major law firm and/o the legal function of a major corporation.
• Practical experience drafting and negotiating contractual agreements.

Preferred

• In house/corporate legal department experience.
• Working knowledge of life-science/pharmaceutical industry.
• Compliance and/or intellectual property experience.
• Knowledge and or experience litigating matters involving intellectual property.
• Understanding of FDA regulations and other laws impacting the pharmaceutical industry, including, the Anti-Kickback Statue, 340B, False Claims Act and PhRMA Code in connection with product labeling, promotional activities, marketing strategies, sales training and compensation, and communications with FDA.
• Experience with clinical trial agreements, ancillary service agreements, registry and observational study agreements, clinical vendor agreements, site management organization agreements, research collaboration agreements, and post approval study agreements.

AAP/EEO Statement

Meitheal is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Summary

About Us:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.

Position Summary:

We are seeking an Associate Director, Commercial Quality, to join our QA team. The Associate Director of Quality position provides Quality Assurance oversight for operational aspects of the Quality department including commercial product shipments and distributions and change control management as well as ensures compliance with required regulations. 

Essential Duties and Responsibilities

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

• Management and Oversight of Quality Assurance Specialists, Commercial Quality and Change Control.
• Responsible for the quality oversight of Meitheal's contract manufacturers.
• Provides quality oversight for Commercial Quality life cycle management by conducting/reviewing Packaging Assessments and Shipping Assessments and reviewing Process Validation protocols/reports for commercialized product. 
• Oversees the batch review process and reviews and approves batch records as needed.
• Oversees the batch shipment and distribution process and Reviews Quality documentation, Certificates of Analysis, Certificates of Conformances and Specification sheets, as needed.
• Reviews internal and external Quality Events including deviations, investigations and risk assessments.
• Oversees the change control process and performs final Quality Review.
• Collects, trends and reports Partner Scorecard data.
• Provides ongoing support to the existing QMS. 
• Collaborates with Product Launch Quality to support New Product Launches, as needed.
• Supports management during external inspections 
• Provide guidance and support in all aspects of cGMP to our Partners.
• Remains current in regulatory trends and requirements.

Supervisory Responsibilities

• QA Specialist direct reports

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 accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Adapt 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.
• Experience communicating with global teams is preferred.
• Ability to manage indirect relationships and projects successfully.
• Elevates issues to management, when appropriate.

Education and/or Experience Required

• Bachelor's degree in life sciences from 4-year college or university. 
• 10 years or progressive, challenging QA/QC experience in the pharmaceutical or related industry. 
• Excellent knowledge of current GMP and GLP as well as FDA trends and guidelines. 
• Strong interpersonal skills. 
• Great attention to detail is necessary. 

Computer Skills

• Proficient in Microsoft Office, Adobe Systems (Pro, Acrobat DC) 
• Quality management systems (TrackWise) preferred but not required.

Work Environment

Why Join Us?

• Be part of a fast-growing company dedicated to making healthcare more accessible and affordable.
• Work in a collaborative and supportive environment that values teamwork and common goals.
• Opportunity to make strategic decisions and have a significant impact on the company's product offerings.
• Hybrid schedule – two days in the office per week.
• Casual dress code.

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.

Apply Now:

If you are passionate about Quality Assurance and want to contribute to a company that values innovation and teamwork, we want to hear from you! Submit your resume and cover letter today to join our dedicated team at Meitheal Pharmaceuticals.

Summary

About Us:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.

Position Summary:

The Associate Director of Product Management for Meitheal's Generics portfolio plays an instrumental role in providing leadership to ensure the product portfolio is properly positioned and developed to drive both short and long-term financial success. This role will focus on portfolio positioning, oversight of new product launch activities, participation in annual budget/forecasting process, monthly S&OP cycle and providing product support to various other internal functions.

Essential Duties and Responsibilities

·       Lead the development of product portfolio plans and strategic initiative to meet organization financial targets, overcome business challenges and drive attainment of market share.

·       Oversee the development of product promotional strategies, partnering with internal and external stakeholders.

·       Work collaboratively with the Market Intelligence, Pricing Analytics, Sales, Contract Marketing and other departments to meet overall product portfolio goals.

·       Provide pricing recommendations and insights to support maximization of product sales and gross profit optimization.

·       Responsible for providing both volume and market share goals as part of Meitheal’s annual budget and forecasting process. 

·       Provide monthly updates as to status of meeting target volume goals and provide recommendations to either further accelerate success or opportunities to overcome volume challenges.

·       Lead review and submission of forecast changes and drivers thereof for monthly S&OP cycle.

·       Lead the execution of assigned new product launches, working cross-functionally to ensure all aspects of product launches are on track to meet product introduction targets.

·       Utilizing multiple inputs provided throughout the organization, serve as the portfolio expert as it relates to product positioning, competitive information, channel penetration and product performance.

·       Lead the development, education and maintenance of product tools (brochures, website, sales collateral, etc.)

Supervisory Responsibilities

·       Supervisory responsibilities include 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. 

·       Bachelor’s Degree in a business-related discipline with at least seven years of increasing responsibility and experience in generic pharmaceutical industry, with preference towards product management, portfolio management or marketing.

·       Ability to understand, translate and integrate multiple data sources into clear and impactful insights to drive decision making.

·       High level of business acumen, analysis and judgement.

·       Strategy development, project management, and problem-solving skills.

·       Exceptional interpersonal communication skills.

·       Ability to build positive working relationships, both internally and externally.

Preferred

·       Advanced degree (MBA/MS)

·       Experience with global operating structures

Education and/or Experience Required

Computer Skills

·       Extensive computer proficiency with desktop software in a Windows environment required: Microsoft Word; Excel; PowerPoint required. Tableau or similar Power BI experience required. 

·       Equal Opportunity Employer Minorities/Women/Veterans/Disabled. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment

Why Join Us?

• Be part of a fast-growing company dedicated to making healthcare more accessible and affordable.
• Work in a collaborative and supportive environment that values teamwork and common goals.
• Opportunity to make strategic decisions and have a significant impact on the company's product offerings.
• Hybrid schedule – two days in the office per week.
• Casual dress code.

Apply Now:

If you are passionate about Product Management and want to contribute to a company that values innovation and teamwork, we want to hear from you! Submit your resume and cover letter today to join our dedicated team at Meitheal Pharmaceuticals.

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:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.

Position Summary:

The Associate, Supply Chain Traceability is responsible for managing the requirements of the Drug Supply Chain Security Act (DSCSA) and ensuring Meitheal is in compliance. This role will be accountable for the reconciliation and verification of inbound and outbound data scans ensuring that our scans match our shipments. This role is responsible for the notification and resolution of serialization efforts with our customers, internal manufacturing sites, and Contract Manufacturing Organizations (CMO’s) in a timely and professional manner. This Associate is responsible for managing relationships with 3rd party logistics providers (3PL), internal, and external Customers. Individual may be tasked with key strategic efforts to drive cost savings and service improvement opportunities. This is a Chicago-based hybrid role.

Essential Duties and Responsibilities

Responsibilities include the following. Other duties may be assigned.

• Develop and implement process and procedures to exchange serialization data with downstream partners
• Function as primary contact for all serialization activities for Meitheal
• Onboard new partners and products for exchange of serialization information
• Resolve data transmission errors and exceptions
• Evaluate and develop internal and external SOPs to ensure Meitheal is in compliance with current and future DSCSA requirements
• Manage master data to ensure accurate data exchange with upstream and downstream trading partners
• Interact various cross-functional teams to provide support and ensure timely completion of tasks in alignment with corporate goals and new product launches
• Be the DSCSA subject matter expert for Meitheal, understanding future serialization requirements, impact to the company and working cross-functionally to ensure compliance by the mandated timeframe

Supervisory Responsibilities

None

Competencies

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

Qualifications

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to remain agile and flexible as the role demands effectively managing several priorities at once, sometimes under deadline pressure and always in a challenging and dynamic environment.
• Detail focused with exceptional organizational skills.
• Proven ability to show initiative and sense of urgency.
• Ability to identify problems and formulate solutions.
• Diplomacy and persuasiveness with internal and external customers.

Why Join Us?

• Be part of a fast-growing company dedicated to making healthcare more accessible and affordable.
• Work in a collaborative and supportive environment that values teamwork and common goals.
• Opportunity to make strategic decisions and have a significant impact on the company's product offerings.
• Hybrid schedule – two days in the office per week.
• Casual dress code.

Education and/or Experience Required

Required

• Bachelor’s degree in Business, Supply Chain, Information Technology, or similar subject area
• 1-3 years of relevant experience

Preferred

• Work experience in pharmaceuticals and/or manufacturing environments
• Knowledge of the Drug Supply Chain Security Act (DSCSA) requirements
• Experience using TraceLink

Computer Skills

MS Office proficiency (Excel, Word, PowerPoint), ERP systems (SAP, Oracle), TraceLink

Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 10 pounds.

Work Environment

The noise level in the work environment is usually moderate.

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.

Apply Now:

If you are passionate about Supply Chain Traceability and want to contribute to a company that values innovation and teamwork, we want to hear from you! Submit your resume and cover letter today to join our dedicated team at Meitheal Pharmaceuticals.

Summary

About Us:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.

Position Summary:

The Director of Brand Marketing for Meitheal's Brand (Contepo and Fertility) portfolio plays an instrumental role in providing leadership to ensure the Brand portfolio is properly positioned and developed to drive both short and long-term financial success. This role leads the marketing strategy including the design and implementation of the marketing/commercial plan to achieve product sales and market share expectations. Specific tactics for these Brands will focus on portfolio positioning, oversight of new product launches, lifecycle management, participation in annual budget/forecasting process and providing product support to various other internal functions.  

Essential Duties and Responsibilities

• Develop and lead the implementation of the marketing plan(s) for the Brand portfolio.
• Build and manage the marketing budget.
• Develop and manage print/digital promotional materials for internal and external stakeholders.
• Manage development, education and maintenance of sales training materials with external vendor.
• Manage vendor relationships, ensuring quality and timely deliverables.
• Lead Meitheal's presence at relevant medical society meetings.
• Manage relationships with patient advocacy organizations.
• Build effective relationships with key opinion leaders (KOLs) in the relevant disease/treatment area(s)
• Adhere to all internal and external legal and regulatory guidelines.
• Oversee the development of product promotional strategies, partnering with internal and external stakeholders.
• Lead the development of product portfolio plans and strategic initiative to meet organization financial targets, overcome business challenges and drive attainment of market share.
• Utilizing multiple inputs provided throughout the organization, serve as the portfolio expert as it relates to product positioning, competitive information, channel penetration and product performance.
• Lead the development, education and maintenance of product tools (brochures, website, sales collateral, etc).

Supervisory Responsibilities

Supervisory responsibilities include one or more direct reports.

Competencies

• Business Acumen
• Judgement
• Cross-functional leadership
• Project Management
• Ethics
• Interpersonal Communication

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 accommodations may be made to enable individuals with disabilities to perform the essential functions:

• Bachelor’s Degree in a business or science related discipline with at least seven years of increasing responsibility and experience in branded pharmaceutical industry, with preference towards product management, portfolio management or marketing.
• Ability to understand, translate and integrate multiple data sources into clear and impactful insights to drive decision making.
• High level of business acumen, analysis and judgement.
• Strategy development, project management, and problem-solving skills. Exceptional interpersonal communication skills.
• Ability to build positive working relationships, both internally and externally.
• Solid understanding of biotech/pharmaceuticals, production forecasting, program and/or alliance management.
• Product launch and brand/portfolio management experience.

Computer Skills

Extensive computer proficiency with desktop software in a Windows environment required: Microsoft Word, Excel; PowerPoint required.  

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.

Apply Now:

If you are passionate about Brand Marketing and want to contribute to a company that values innovation and teamwork, we want to hear from you! Submit your resume and cover letter today to join our dedicated team at Meitheal Pharmaceuticals.

Summary

Company Overview:

Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a pioneering company dedicated to the development and commercialization of generic injectables. Expanding its horizon to fertility, biologics, and biosimilars since 2022, Meitheal markets over 50 FDA-approved products across various therapeutic areas, including anti-infectives, oncolytics, intensive care, and fertility. With a robust pipeline, Meitheal aims to provide accessible and fairly priced products while embodying the spirit of "Meitheal," an Irish principle of working together for the greater good.

Summary

The Major Account Executive will be responsible for developing long term business partnerships within an assigned territory that include(s) Integrated Delivery Networks (IDN’s) and Regional Key Customer(s) across both acute and non-acute markets for generic pharmaceuticals. This role reports to the Director of Sales and will work closely with the Company’s internal departments including National Accounts and Marketing to meet agreed upon goals. This is a field-based position and is preferred that candidates be located within the assigned geographical territory (Northeast).

Essential Duties and Responsibilities

Essential Duties and Responsibilities



• Responsible for gaining access at the highest level within the assigned IDN and Regional Key

Customers to deliver the Company’s story and vision of partnership.

• Establishes and deepens relationships of key decision makers within assigned organizations.

• Identifies and drives opportunities with assigned customers, and develops strategies to gain and increase sales, product share, revenue, and profit through compliance to GPO, Individual and Company-based agreements.

• Provides market intelligence to internal teams as requested.

• Conducts quarterly business reviews with customers to drive contract compliance, discover unmet opportunities and position the Company’s future products.

• Travel as required, to the Company’s corporate office in Chicago for meetings with commercial team.

• Other duties may be assigned.

Competencies

Competencies



• Business Acumen

• Critical Thinking Skills

• Analytical Skills

• Communication

• Negotiating Skills

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

• High level of business acumen, analysis and judgement.

• Strong analytical skills and attention to detail.

• Must have prior experience selling and working with major IDN’s or Regional Key Customers.

• Knowledge of Generic Injectable Drugs and history of drug shortages required.

• Must understand relationship dynamics the assigned customer has with Group Purchase Organizations (GPO’s) and Wholesaler/Distributors, and the types of contracts offered by both.

• Ability to effectively communicate and negotiate on behalf of the Company at all levels within assigned IDN’s and Regional Key Customer(s).

• Ideal candidate must have experience in selling and contracting current and future products at the health system level.

• This role requires up to 50% travel domestically.

Education and/or Experience Required

• Bachelor’s Degree in a business-related discipline.

• A minimum of 10 years of experience in pharmaceutical sales (generic injectables preferred).

• Experience in new molecule launches and pipeline analysis.

Computer Skills

Microsoft Word, PowerPoint, Excel.

Work Environment

This role is field-based role.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

About Us:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.

Position Summary:

We are seeking a Quality Assurance Specialist to join our QA team. This role is essential in ensuring Meitheal’s standards and requirements are met for routine product shipments and distributions. 

Essential Duties and Responsibilities

Performs review and approval of QA documentation for all Meitheal batch disposition activities, including:

• Batch Record review per the applicable review frequency.
• Review of COA, COC, and Quality documentation supporting shipment authorization of products manufactured for Meitheal prior to shipment.
• Review of Partner’s investigations for adequate root cause analysis.
• Review of temperature profiling data.
• Disposition product.
• Provide guidance and support in all aspects of cGMP to our Partners.
• Remains current in regulatory trends and requirements.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Adapt to changing environments.
• Ability to prioritize and multitask.
• Organized and detailed orientated. 
• Has a sense of urgency to meet all required deadlines.
• Ability to manage indirect relationships and projects successfully.
• Elevates issues to management, when appropriate.

Education and/or Experience Required

Education and/or Experience

• Bachelor's degree in life sciences from 4-year college or university. 
• 1-3 years QA/QC experience in the pharmaceutical or related industry; or equivalent combination of education and experience. 
• Excellent knowledge of current GMP and GLP as well as FDA trends and guidelines. 
• Strong interpersonal skills 
• Great attention to detail is necessary. 

Preferred

• Background in aseptic processing, preferably with injectables, and 
• Experience with complex generics, drug-device combination productions, biosimilars, or biologics is a plus.

Computer Skills

• Proficient in Microsoft Office, Adobe Systems (Pro, Acrobat DC) and 
• Quality management systems (TrackWise) preferred but not required

Work Environment

Why Join Us?

• Be part of a fast-growing company dedicated to making healthcare more accessible and affordable.
• Work in a collaborative and supportive environment that values teamwork and common goals.
• Opportunity to make strategic decisions and have a significant impact on the company's product offerings.
• Hybrid schedule – two days in the office per week.
• Casual dress code.

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.

Apply Now:

If you are passionate about Quality Assurance and want to contribute to a company that values innovation and teamwork, we want to hear from you! Submit your resume and cover letter today to join our dedicated team at Meitheal Pharmaceuticals.

Summary

About Us:

Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a trailblazing company committed to the development and commercialization of generic injectables. Recently, we've expanded into fertility, biologics and biosimilars, now marketing over 50 FDA-approved products across various therapeutic areas. We embody the Irish principle of "Meitheal," fostering teamwork toward common goals, ensuring accessibility and affordability for all.

Job Summary:

Senior Director of Regulatory Affairs, Specialty Pharma, will be responsible for leading regulatory strategy for specialty pharma products, especially combination products in development and life cycle management, including A/NDA products and biosimilars.  S/he will work closely with cross-functional teams within the Company and across business partners, to prepare, review and finalize regulatory submissions, and play a critical role in the transformation and growth of regulatory team to meet the needs of company's business growth toward biopharmaceuticals.  

Why Work with Us?

• Hybrid Work Schedule: Enjoy the flexibility to work remotely two days a week, balancing your professional and personal life.
• 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

• Provide strategic regulatory guidance on specialty pharma, especially combination products to senior management and specific project teams, from portfolio development, project execution to life cycle management. 
• Work closely with cross-functional teams and external consultants to ensure regulatory compliance throughout combination product development.
• Proactively identify possible regulatory risk or issues and recommend mitigation measures or solutions.
• Prepare and participate in FDA meetings and EMA Scientific Advisory meetings for product development (Biosimilars, generic and innovative products), with focus on drug-device combination products.
• Prepare and review regulatory submissions and deficiency responses to FDA, EMA, and other regulatory agencies.
• Work with Head of Regulatory Affairs department to build up competence and capacity to enhance the efficiency and productivity of project execution as well as the approvability of submissions. 
• Provide support to CMC and regulatory sciences of specialty pharma products, including biosimilars/biologics.

Competencies

Language Skills

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Qualifications

Language Skills

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Education and/or Experience Required

• Bachelor, Master, or Ph.D. 's degree in life sciences. An advanced degree is preferred.
• Over 10 years related experience in product development and regulatory strategy, and/or regulatory affairs, with a minimum of 3 years in combination product area. 
• Must have experience in preparing comprehensive packages for meetings with FDA and other regulatory agencies, developing regulatory strategies to streamline development process for efficiency and cost-effectiveness, as well as addressing challenges and deficiencies of technical complexity.
• Expertise in drug-device combination products, including peptides, biologics or biosimilars, are highly preferred.

AAP/EEO Statement

Benefits:

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Generous PTO and paid holidays.
• Retirement savings plan with company match.
• Professional development and training opportunities.

How to Apply:

Ready to join a company that values your expertise and offers a flexible and supportive work environment? Apply today to join the Meitheal team and contribute to our mission of fostering teamwork towards common goals.

Join us at Meitheal, where innovation meets flexibility. Let’s build the future together!

Meitheal is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Summary

Company Overview:

Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.

Job Summary:

The Senior Director/Director of Regulatory Affairs, Biopharma, will provide regulatory guidance for (Bio)Pharma product development and tech transfer, especially biosimilars. This role involves preparing and reviewing submissions and working closely with cross-functional teams within the company and across business partners. The successful candidate will develop regulatory strategies for projects and portfolios in BioPharma, contributing to the transformation and growth of the regulatory team to meet the company's business growth towards biopharmaceuticals.

Essential Duties and Responsibilities

Essential Duties and Responsibilities:

• Thoroughly understand US regulatory guidance on biosimilars; track and interpret new guidance and requirements, assessing their impact on product development.
• Represent the regulatory function on cross-functional developmental teams for biosimilars, collaborating with Operations, Quality, Legal, and Marketing groups.
• Prepare and review meeting packages and submissions, including BIA, BPD, INDs, BLAs, etc.
• Serve as an interface with other regulatory groups in development, manufacturing, clinical partners, and consulting services.
• Lead preparation and management of meetings with health authorities, such as US FDA, EMA.
• Guide the project team on the most appropriate regulatory approach from development through approval and provide post-market support.
• Conduct due diligence and review documents from global business partners for technical and regulatory compliance.
• Collaborate with the Head of Regulatory Affairs to build competence and capacity for biosimilars and biologics.
• Provide training on CMC and regulatory sciences for biologics and biosimilars within the RA department and cross-functions.
• Support CMC and regulatory sciences of complex generics, especially peptide generics.

Supervisory Responsibilities

Supervisory Responsibilities:

• Supervise 1-3 direct reports.

Qualifications

Qualifications:

• Bachelor’s, Master’s, or Ph.D. degree in life sciences.
• Over 8 years of related experience in product development and/or regulatory CMC, with a minimum of 3 years in biologics and/or biosimilars.
• Expertise in and experience with Regulatory Affairs of biosimilars are highly preferred.

Computer Skills

Computer Skills:

• Proficiency in Microsoft Office, Adobe Systems (Pro, Acrobat DC), etc.

Physical Demands

Travel:

• Occasional travel expected (<10%).

AAP/EEO Statement

AAP/EEO Statement:

Meitheal Pharmaceuticals is an Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

If you are passionate about regulatory affairs and eager to contribute to the growth of a dynamic pharmaceutical company, we encourage you to apply for this exciting opportunity. Join us at Meitheal Pharmaceuticals, where teamwork and innovation drive our mission to improve patient access to essential medications.