South San FranciscoFull TimeData Science
Remotely
regulatory affairsregulatory submissionscmcall otherindchange controlctas
Job Description
📋 Description
- Lead CMC regulatory product strategies and submissions (INDs/CTAs, amendments, variations)
- Collaborate with product development, RA, Operations, and R&D teams
- Represent CMC with regulatory agencies (e.g., FDA) as strategic liaison
- Prepare and manage regulatory submissions and responses
- Lead pre-meeting content and engagement with agencies
- Oversee change control and product/line approvals
🎯 Requirements
- Bachelor’s Degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering or related field
- 8 years pharma experience with 3+ years in leadership
- 10 years pharma experience preferred; 5+ in regulatory affairs or 5+ in
- Experience with global regulatory strategies and Health Authority interactions
- Strong oral and written communication; ability to work in a matrix environment
- Higher education may compensate for years of experience
🎁 Benefits
- Competitive compensation and benefits package
- Long-term incentive programs eligibility
- Comprehensive health and retirement benefits
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