Director, Regulatory Affairs - CMC/Biologics
ICON · Blue Bell +1 more
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Role summary
ICON seeks a Director of Regulatory Affairs with expertise in CMC strategy for biologics and small molecules. The role involves managing regulatory submissions (INDs, NDAs, BLAs), advising internal teams and clients on development and manufacturing, and navigating FDA requirements across preclinical through post-approval phases. A relevant bachelor's degree and demonstrated CMC regulatory experience in pharmaceutical or biologics development are required.
What they're looking for
- Bachelor's degree in life sciences or healthcare field
- CMC regulatory experience in global pharmaceutical or biologics environment
- Technical knowledge of small and large molecule development, testing, manufacturing
- Demonstrable experience in regulatory CMC strategy and documentation during drug development
- RAC certification or advanced degree in biological, medical, chemical, or engineering field
What you'll be doing
- Provide technical expertise on biologics development, testing, and manufacturing to colleagues and clients
- Prepare and manage regulatory CMC submission documents for IND, NDA, BLA, NDS, ANDA applications
- Lead communications and negotiations with clients, government agencies, and project teams for submission approvals
- Develop regulatory strategies and provide strategic advice to clients on CMC-related queries
- Support preclinical through post-approval activities and serve as US Agent for client submissions
Privacy & handoff
This role links to ICON's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.