Regulatory Strategy Director, Renal
Vertex Pharmaceuticals · Paddington, UK
RegulatoryFull-timeCompany career page
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Role summary
Vertex Pharmaceuticals seeks a Regulatory Strategy Director to provide global regulatory leadership for renal therapy programs. This role involves developing regulatory strategies across development phases, leading health authority interactions, and collaborating with cross-functional teams to advance investigational assets while supporting business objectives.
What they're looking for
- Advanced degree in scientific, medical, or health-related field; bachelor's degree minimum
- Significant biopharmaceutical regulatory affairs experience with development-stage and marketed products
- Deep knowledge of global regulatory requirements and drug development processes across major markets
- Demonstrated ability to develop and communicate clear regulatory strategy to senior leadership
- Strong leadership and influencing skills in matrixed, cross-functional environments
- Experience leading complex regulatory submissions and US/ex-US health authority interactions strongly preferred
- Background in renal, nephrology, rare disease, or specialty therapeutic areas preferred
What you'll be doing
- Develop and execute global regulatory strategies for renal therapy programs across all development phases
- Lead planning and execution of health authority interactions including meeting strategy and agency responses
- Drive regulatory strategy and execution for major submissions including INDs, NDAs, BLAs, MAAs, and post-approval filings
- Serve as regulatory representative on cross-functional program teams providing strategic development guidance
- Monitor evolving global regulations and competitive developments; mentor regulatory team members
Privacy & handoff
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