South San FranciscoFull TimeHealthcare
Remotely
regulatory affairsglobal regulatory strategyregulatory submissionscmcctaind
Job Description
📋 Description
- Prepare CMC regulatory product strategies
- Manage regulatory submissions and amendments
- Analyze data for regulatory decisions
- Lead agency meeting prep and content
- Manage change control with regulations and policies
- Collaborate with cross-functional teams for first pass approvals
🎯 Requirements
- Bachelor’s in Pharmacy, Chemistry, Biology, or Pharmacology, Engineering
- 8 years pharma exp with 3+ years leadership
- 10 years pharma exp incl 5+ in RA or 5+ in Discovery/R&D/Manufacturing
- Global regulatory strategy experience with Health Authorities
- Strong oral and written comms
🎁 Benefits
- Comprehensive benefits package includes PTO, medical/dental/vision
- 401(k) to eligible employees
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