Director Regulatory CMC
Meet Life SciencesHighlight
Summary
About the Role
About You
- B.S./M.S. in a scientific discipline (Chemistry, Biology, or Pharmacy); A Ph.D. or PharmD is highly preferred.
- 10+ years of experience in the biopharmaceutical industry, with at least 7 years focused specifically on CMC Regulatory Affairs.
- Successful track record of contributing to at least one major marketing application (NDA or BLA) from initial drafting through approval.
- Strong understanding of GMP (Good Manufacturing Practices) and ICH guidelines.
- Deep knowledge of FDA, EMA, ICH regulations, and global regulatory requirements.
- Ability to interpret complex technical data (e.g., mass spectrometry, impurity profiles, dissolution data) and present it in a regulatory-compliant narrative.
- Exceptional communication and interpersonal skills, with the ability to effectively interact with cross-functional stakeholders and senior leadership.
Benefits
- Estimated base salary range of $275k–$280k.
- Eligible for two annual cash bonuses.
Life Sciences Affects Us All. At Meet, we champion the people who work in Life Sciences, share the purpose of the companies who innovate in it and create the teams that drive the future of global health. With companies looking to find the best talent to move forward and life sciences professionals eager to hear about the opportunities to give them a career they want - Meet listens, engages and understands you. Making your experience with us a memorable one. At Meet, we offer dynamic talent solutions covering recruitment, volume hiring and consulting. Our teams focus on specific Life Sciences disciplines, positioning themselves as experts in the industry. Our philosophy is simple; to provide exceptional, personalised service. But realising it takes dedication and hard work. This is why we’ve assembled such a remarkable team of professionals to make it a reality for you: people with passion, people with talent, people with chemistry.