Senior Associate, Regulatory Affairs - CMC
About The Position
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.
Requirements
- 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.
- MS Office proficiency (Excel, Word, PowerPoint)
- Assimilate to changing environments.
- Ability to prioritize and multitask.
- Organized and detailed orientated.
- Have a sense of urgency to meet all required deadlines.
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 CMC and Labeling change controls from global R&D, QC, manufacturing sites and CMOs.
- Adhere to submission timelines as per the internal tracking. Administration and management of assigned products.
- 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.
- Maintains sound knowledge of regulations, policies/guidelines and keep abreast with evolving regulatory CMC requirements.
- Perform other duties as assigned by the Supervisor.
- Other duties may be assigned.
Benefits
- Competitive pay and medical, dental, and vision insurance
- Flexible spending accounts
- Long- and short-term disability insurance, as well as life insurance
- 401(k) plan with employer contribution
- Competitive PTO and company-paid holidays
- Paid parental leave (maternity & paternity)
- Onsite gym
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What This Job Offers
Job Type
Full-time
Career Level
Senior
