South San FranciscoFull TimeData Science
Remotely
regulatory affairsregulatory complianceregulatory submissionscmcall otherfdaindctas
Job Description
📋 Description
- Prepares CMC regulatory product strategies and manages submissions
- Analyzes information impacting regulatory decisions; seeks expert advice as needed
- Reviews and revises submissions to present data to agencies
- Develops strategies for agency meetings; manages content of submissions
- Manages product changes and change control per regulations and policies
- Represents CMC RA on cross-functional teams to drive first pass approvals
🎯 Requirements
- Bachelor's Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related
- 8 years pharmaceutical with at least 3 years of leadership
- 10 years pharmaceutical experience including 5+ years in regulatory affairs or 5+ years in
- Experience developing and implementing global regulatory strategies; experience with Health
- Experience in a complex and matrix environment
- Strong oral and written communication skills
🎁 Benefits
- Competitive benefits package including paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k) plan to eligible employees
- Eligible to participate in long-term incentive programs
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