South San FranciscoFull TimeData Science
Remotely
machine learningbiotechregulatory compliancepharmaaiall other
Job Description
📋 Description
- Lead regulatory function across three therapeutic areas and modalities
- Develop global regulatory strategies for small molecules, biologics, and diagnostics
- Role can be onsite 3 days/wk in South San Francisco or hybrid ~1 week/mo
- Interface with FDA, EMA, and global authorities; ensure regulatory compliance
- Drive risk mitigation and data-driven go/no-go decisions
- Shape AI/ML regulatory landscape and policy engagement
🎯 Requirements
- 10+ years in regulatory affairs in biotech/pharma
- Clinical delivery track record from first-in-human to NDA/BLA
- Advanced life sciences degree; regulatory science specialization preferred
- Strong command of GxP, trial design, pharmacology, biostatistics
- Cross-functional leadership and startup-building experience
- Computational regulatory experience with AI/machine learning a plus
🎁 Benefits
- Salary: $313,000 – $333,000 (USD)
- Annual bonus plan and equity incentives
- 401(k) with employer match; comprehensive health benefits
- Flexible vacation; paid parental leave; learning stipend
- Home office setup stipend and stipends for mobile/internet
- Commuter bus access to South San Francisco HQ
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