Director, Regulatory CMC
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Job Location:
San Francisco, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Director Regulatory CMC
Location: San Francisco CA (Onsite 4 days/week)
Industry: Biotechnology / Pharmaceutical
Job Summary
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
- Bachelors 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
