Associate Director, CMC Regulatory Affairs
About The Position
The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. The role leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities on CMC topics. It provides regulatory guidance to cross-functional teams and ensures applicable global regulatory requirements are considered and incorporated into investigational and commercial products. The role may supervise other regulatory staff. The position also participates in department strategy development and implementation, providing recommendations in its area of expertise. Vertex describes itself as a global biotechnology company that invests in scientific innovation and encourages employees to stay informed about advances in AI, technology, automation, and industry trends.
Requirements
- Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another life-science field.
- Typically 8 years of experience in the pharmaceutical or biotech industry or a related field, or an equivalent combination of education and experience.
- Advanced knowledge of regulatory guidelines, including FDA, EMA, Health Canada, and ICH.
- Excellent interpersonal skills to communicate difficult concepts and persuade others.
- Strategic thinking and strong problem-solving skills.
- Ability to collaborate and communicate in an open, clear, complete, timely, and consistent manner.
- Strong planning and prioritization skills and the ability to work with all levels of management.
Responsibilities
- Lead the preparation and review of CMC sections of regulatory submissions, as well as interactions and responses with regulatory agencies.
- Develop global CMC regulatory strategies for one or more investigational and/or marketed products.
- Lead regulatory colleagues in developing global CMC regulatory strategies and submissions.
- Provide CMC regulatory guidance to cross-functional teams and key stakeholders.
- Manage regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations.
- Lead projects with cross-functional teams and act as the primary regulatory CMC contact for assigned products and projects.
- Participate in designing, developing, and implementing department strategies, providing recommendations in the area of expertise.
Benefits
- Annual bonus eligibility
- Annual equity awards
- Medical, dental, and vision benefits
- Generous paid time off, including a week-long company shutdown in the summer and winter
- Educational assistance programs, including student loan repayment
- Commuting subsidy
- Matching charitable donations
- 401(k)
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What This Job Offers
Job Type
Full-time
Career Level
Director
