Senior Vice President, Regulatory Affairs
Mineralys Therapeutics · Remote
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Role summary
Mineralys Therapeutics seeks a Senior Vice President of Regulatory Affairs to lead global regulatory strategy for its clinical-stage biopharmaceutical portfolio. The role combines strategic oversight of submissions, agency relationships, and compliance across the product lifecycle with executive leadership of the regulatory function and team development.
What they're looking for
- 15+ years of progressively responsible regulatory affairs experience in biopharmaceuticals
- Successful NDA submission experience and major health authority interactions; MAA experience preferred
- Proven track record leading regulatory strategy for lifecycle expansion and global launches
- Experience in commercial-stage biotech/pharma with knowledge of labeling, promotional review, post-marketing commitments
- Mastery of ICH guidelines, FDA and EMA post-marketing regulations, and CMC lifecycle requirements
- Small molecule and cardiometabolic disease experience preferred
What you'll be doing
- Drive global regulatory strategy in partnership with Clinical Development on plans, trial designs, and endpoints
- Oversee health authority interactions, product labeling decisions, and safety change submissions
- Lead global post-approval submissions including supplemental NDAs, line extensions, and manufacturing variations
- Build ex-US regulatory approach across priority markets using reliance and joint-review pathways
- Build and lead high-performing global Regulatory Affairs team with clear accountability and succession planning
Privacy & handoff
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