We are seeking an experienced Director, Regulatory CMC (Chemistry, Manufacturing, and Controls) to join a growing biotech organization. This role will lead regulatory strategy and execution for CMC activities across development programs, with exposure to both small molecules and biologics.
The ideal candidate will bring strong expertise in global regulatory requirements and play a key role in supporting product development, submissions, and lifecycle management.
Key Responsibilities
Lead and develop CMC regulatory strategies to support clinical development and commercialization
Prepare and review regulatory submissions (INDs, NDAs, BLAs, amendments, and supplements)
Ensure compliance with FDA, EMA, and global regulatory requirements
Collaborate cross-functionally with CMC, Quality, Manufacturing, and Clinical teams
Provide regulatory guidance on process development, manufacturing changes, and product lifecycle management
Support interactions with regulatory agencies, including meeting preparation and responses
Oversee preparation and review of Module 3 (CMC) documentation
Stay current with evolving regulatory requirements and industry trends
Required Qualifications
Bachelor s degree in Life Sciences, Chemistry, or related field (advanced degree preferred)
10+ years of experience in Regulatory Affairs (CMC) within biotech/pharma
Strong experience with IND, NDA, BLA submissions
Experience with both small molecules and/or biologics (both preferred)
Deep understanding of global regulatory guidelines (FDA, EMA, ICH)
Excellent communication, leadership, and stakeholder management skills
Seniority level
Director
Employment type
Contract
Job function
Legal
Industries
Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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