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 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, South Central covers the following states: AL, AR, IA, MO, MS, NE, OK, TX

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.

Supervisory Responsibilities

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.

Education and/or Experience Required

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 Marketing Manager for Meitheal's Brands (CONTEPO and XENLETA) 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 marketing planning and execution, including the design and implementation of marketing strategies, conference and event strategies, and sales support to achieve product sales and market share expectations. Specific tactics for these Brands will focus on developing digital marketing channels that leverage paid, organic, and earned media sources to generate leads and foster existing customer relationships, support new product launches and lifecycle management, and provide product support to various internal functions including sales.

The compensation range for this position is $100,000 to $150,000

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.



• Develop and lead the implementation of the marketing campaigns for the Brand portfolio. 
• Develop and lead print/digital promotional materials for internal and external stakeholders. 
• Lead the development, education and maintenance of product tools (brochures, website, sales collateral, etc.). with external vendors. 
• Collaborate with the sales team to conceptualize or iterate on marketing materials.
• Manage vendor relationships, ensuring quality and timely deliverables. 
• Lead the planning and management of conferences, society meetings, and displays for the Brand portfolio.
• Lead the planning and management of corporate sponsored events for the Brand portfolio.
• Manage the advertising and promotional approval process for the Brand portfolio's promotional materials.
• Adhere to all internal and external legal and regulatory guidelines. 

Supervisory Responsibilities

None

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. 

• Bachelor’s Degree in a business or science related discipline with at least five years of experience in branded pharmaceutical industry, with preference towards product 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. 
• 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. 
• Solid understanding of the advertising and promotional process for Branded biotech/pharmaceuticals. 
• Conferences, event management, and planning experience.
• Experience working in a cross-functional environment.
• Product launch and brand/portfolio management experience. 

Preferred

• Advanced degree (MBA/MS.)
• Experience with global operating structures.
• Experience with Veeva PromoMats.

Computer Skills

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

Sr. Analyst, IT Support is responsible for monitoring and managing the daily operations of the IT department, managing technical teams (internal / external resources) as needed, implementing and monitoring cybersecurity measures to protect company data and ensuring the organization’s technology infrastructure runs smoothly.

The pay range for this position. 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.

Why Work with Us?

• 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

• Oversee the installation, configuration, and maintenance of hardware, software, and networks.
• Ensure system security, data integrity, and backup processes.
• Monitor system performance and troubleshoot issues promptly.
• Manage help desk operations to resolve user issues effectively.
• Develop and enforce IT support procedures and service-level agreements (SLAs).
• Manage relationships with third-party vendors and service providers.
• Evaluate and recommend new technologies, tools, and systems.
• Implement and monitor cybersecurity measures to protect company data.
• Ensure compliance with industry regulations and company policies.
•  Assist in developing and managing the IT budget.
• Review and advise on the purchases of all hardware, software, and automation-related services.
• Ensure sufficient systems capacity for immediate organizational needs and plan appropriately for the future.
• Identify opportunities for process improvements and technology upgrades.
• Stay updated on industry trends and emerging technologies.
• Assign tasks and projects to team members (internal and external) based on skills and workloads.

Supervisory Responsibilities

None

Competencies

• Strong problem-solving abilities with a customer focus
• Detail focused with exceptional organizational skills 
• Strong written and oral communication skills
• Able to build and manage relationships with others
• Effective cross-functional team member, as a leader and team member
• Adaptability and Flexibility
• Strategic Thinking; skilled at troubleshooting and mitigating risks
• Cost conscious
•  Address user and team concerns diplomatically

Education and/or Experience Required

Education and/or Experience

• Bachelor’s degree or equivalent work experience in information technology, network administration, or related field
• 3–5 years of hands-on experience in IT support, systems administration, network management, or infrastructure management.
• Proficient in Office 365, MS exchange email, and Share Point. 
• Experience managing IT projects, including system upgrades, network implementations, and software deployments.
•  Knowledge of cybersecurity best practices and regulatory compliance.
• Experience with help-desk management systems and IT support tools.

Language Skills

Ability to read, analyze, and interpret 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 employees at all levels of the organization.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to identify potential risks and mitigate such risks to ensure on-time deliveries.

Computer Skills

• Operating Systems: Windows Server, Linux/Unix, macOS
• Network Management: TCP/IP, DNS, DHCP, VPN, VLAN, and firewall configurations
• Active Directory (AD): User and group management, Group Policy Objects (GPO)
• Virtualization: VMware, Hyper-V, or VirtualBox for server and desktop virtualization
• Cloud Platforms: AWS, Microsoft Azure, Google Cloud Platform (GCP)
• Cloud Services: Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Software as a Service (SaaS)
• Security Protocols: SSL/TLS, VPN, multifactor authentication (MFA)
• Compliance Standards: GDPR, HIPAA, PCI DSS, ISO/IEC 27001
• Hardware Knowledge: Servers, desktops, laptops, network devices, and mobile devices
• Collaboration Platforms: Microsoft Teams, Slack, Zoom

Work Environment

Travel

• This position requires occasional 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 Meitheal

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 brand products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytic, 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 in2024 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 Senior Associate is responsible for providing effective support to the Publishing Operations function in Regulatory Affairs. The responsibilities for this position include utilizing publishing systems and processes for the preparation of high-quality submission dossiers, ensuring compliance with the FDA regulations and internal policies/procedures. Pharmaceutical experience required.

The estimated salary range reflects an anticipated range for this position of $70,000 to $85,000. 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.

Essential Duties and Responsibilities

• Prepare, compile, publish, validate, and submit electronic regulatory submissions (eCTD) for ANDA, NDA, BLA, IND, and DMF applications.
• Manage pre-approval, post-approval, and lifecycle management submissions, including Annual Reports, PADERs, PAS, CBE-0, CBE-30, Amendments, Supplements, and Safety Reports.
• Publish and submit Promotional and Advertising materials in compliance with FDA OPDP/2253 requirements.
• Perform advanced quality control (QC) reviews of submission components, including XML backbone, metadata, hyperlinks, bookmarks, file naming conventions, and validation reports.
• Submit eCTD submissions through the ESG FDA gateway, ensuring all components meet eCTD format requirements in collaboration with the publishing operations lead.
• Handle ANDA, NDA, and BLA submissions for pre-approval, post-approval, and promotional materials, supporting full product lifecycle management.
• Develop and maintain an in-depth understanding of relevant US and EU regulatory requirements for submissions.
• Troubleshoot and resolve complex technical issues related to publishing systems, validation errors, gateway rejections, large file handling, and system performance.
• Perform administrative tasks related to submissions, including transferring files via FTP servers.
• Input submission information into internal databases and systems per company procedures.
• Perform other duties as assigned to support Regulatory Affairs publishing operations.

Supervisory Responsibilities

None

Competencies

• Planning and Organizing
• 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 accommodations 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

Bachelor's degree from a 4-year college or university; over 3-4 years pharma experience and/or training; or equivalent combination of education and experience.

Computer Skills

Excellent dexterity: Microsoft Office (Word, Excel, Power Point and Outlook), Adobe Systems (Pro, Acrobat DC), and Practice Database system (DocuBridge, Veeva Systems, eCTD Manager, Liquent Insight publisher, etc.).

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.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

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:

Senior manager of Regulatory Affairs, CMC & Regulatory Sciences will be responsible for providing regulatory guidance to product development, supporting and reviewing CMC sessions in submissions & deficiency responses, aiming for efficient and robust product development and high-quality regulatory submissions, primarily for biosimilars. S/he will work closely with the management team of Regulatory department to develop regulatory strategies for both projects and portfolios of biosimilars, contributing to the transformation and growth of regulatory team to meet the needs of company's business growth toward biopharmaceuticals.

The salary range for this position is $120,000 to $125,000. 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.

• Contribute to regulatory strategy in new projects and portfolio.

• Provide regulatory guidance and advice to partners in development, technology transfer and manufacturing

• Manage the regulatory aspects of products and projects, including achievement of timelines and deliverables to align with corporate and departmental goals.

• Prepare, review communication documents & submissions to the agencies, including controlled correspondence, NDAs, ANDAs, BIA, BPD2/3, BLAs, etc.

• Work and address complex and technical issues with solid scientific rationalization.

• Identify and act on issues and risks from a regulatory perspective, especially for complex generics.

• Provide due diligence and review documents from domestic and international partners for technical and regulatory compliance.

• Provide regulatory assessments to the company (internal and partners), including change controls and/or document changes based on ICH and FDA guidelines.

• Represent the regulatory function on cross-functional developmental teams primarily with Operation, Quality, Legal and Marketing groups.

• Track and interpret FDA new guidances & new requirements, and assess their impact on product development, including expertise, timeline and budgeting.

• Support business development efforts

• Track deficiency trends, develop proactive and/or mitigation measures accordingly

• Provide training on regulatory sciences within Regulatory Affairs department and cross-functions.

Supervisory Responsibilities

None

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.

Education and/or Experience

Master or Ph.D. 's degree in life sciences; over 6 years related experience in product development and/or regulatory CMC; or equivalent combination of education and experience. Expertise in and experience with the development of biologics and/or biosimilars, especially drug substance manufacturing, upstream and downstream process development, and characterization, are highly preferred.

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. The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

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 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 2025, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.

Summary

The Staff Accountant position supports the Company’s high growth objectives, goals and strategies under the guidance of the Associate Director of Accounting. The Staff Accountant position supports the month end close process, performs accounts receivable (including gross to net adjustments) and other projects as needed. 

The pay range for this position is $75,000 to $110,000. 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

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

• Assists in month end close process, including revenue, inventory, fixed assets, prepaids and supply chain accounting, reconciliation and analysis.

• Analyzes, processes and resolves chargebacks items to establish appropriate credit within the contractual requirements through extensive research of EDI submissions to resolve discrepancies between wholesaler requests for credit and the Meitheal chargeback system.

• Performs corporate accounts payable and accounts receivable functions. 

• Reviews results on a monthly basis and provides variance analysis.

• Prepares and maintains accounting documentation, including technical accounting research on complex accounting issues and documents the position papers.

• Independently and timely perform non-recurring, one-off projects and other analyses as delegated by the Controller.

Supervisory Responsibilities

None

Competencies

 Business Acumen

• Positive Attitude

• Business/Financial Acumen

• Ethics and Values

• Motivation

• Critical Thinker

• Team Player

• Strong Analytical Skills

• Technologically Proficient

• Professionalism

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. 

• Ability to utilize advanced finance and accounting experience to manage assigned workload.

• Working knowledge of corporate financial statements, including balance sheet, income statement, and related analytics, including cost center review and comparison to budget and forecast.

• Able to quickly establish a personal brand within the organization to drive cross functional collaboration.

• Curious mindset that proactively seeks understanding and feedback.

• Excellent communication skills

Education and/or Experience Required

• Bachelor’s degree in accounting, Finance or related areas is required.
• CPA is required.
• 3-4 years’ accountancy experience required.
• Minimum of 1-3 years of experience with pharmaceutical industry experience preferred. 
• Big 4 Experience highly preferred.
• Solid understanding of U.S. GAAP and management reporting and analysis.

Computer Skills

Microsoft Word, PowerPoint and Excel

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.