VP, Head of Regulatory
Location
United States
Posted
4 days ago
Salary
$350K - $400K / year
Seniority
Lead
Job Description
VP, Head of Regulatory
Enveda
• Define and execute global regulatory strategies across early- and late-stage development for small molecules and combination products • Lead and oversee interactions with FDA, EMA, and other global regulatory agencies • Author, review, and submit key regulatory documents, including INDs, CTAs, briefing books, and response packages • Build and manage a high-performing regulatory team across strategy, operations, and publishing
Job Requirements
- Advanced degree (PhD, PharmD, MSc, or JD) in life sciences or regulatory sciences
- 15+ years of global regulatory affairs experience in biotech/pharma, including successful submissions
- Experience leading regulatory strategy for first-in-class or novel MOA products
- Strong written and verbal communication skills with the ability to represent the company with regulators and external partners
Benefits
- 90% Medical, Dental, Vision
- 401k Match
- Flexible PTO
- Adoption Assistance
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