Overview:
Celldex is seeking an Associate Director, Regulatory CMC. Reporting to the Head of Regulatory CMC, the Associate Director will develop strategies, author high-quality regulatory submissions (especially Module 3), and support product approvals through all development stages.
Key Responsibilities:
- Lead global CMC regulatory strategies for combination products
- Author and review Module 3 for INDs, BLAs, and global filings
- Represent Regulatory CMC on cross-functional teams
- Prepare for and participate in regulatory meetings, addressing CMC-related questions
Required Qualifications:
- 8+ years of Regulatory CMC experience
- Proven expertise in Module 3 authoring for INDs/BLAs
- 3+ years working with drug-device combination products
- Strong BLA submission experience and project leadership skills
Preferred:
- Experience with drug delivery devices (e.g., prefilled syringes, autoinjectors)
- Familiarity with eCTD publishing and global regulatory systems (EMA, PMDA, etc.)
Job sourced from Celldex.