Senior Director Regulatory Strategy
Senior Director, Regulatory Affairs - Clinical-Stage Oncology Biotech
ABOUT THE ROLE The Senior Director, Regulatory Affairs, will set and lead regulatory strategy at a defining point in the company's growth. This is a rare chance to build a regulatory function from the ground up, with real ownership and visibility to senior leadership.
DESCRIPTION OF THE ROLE The Senior Director, Regulatory Affairs, is expected to:
- Develop and carry out regulatory strategy from development through approval and commercialization
- Lead preparation and submission of major filings (IND, NDA, MAA)
- Serve as a primary contact with FDA and global health authorities, and prepare teams for and lead agency meetings
- Act as the strategic regulatory partner to R&D, Clinical Development and Quality
- Spot regulatory risks early and put proactive mitigation plans in place
- Keep up to date on changing FDA and international requirements and keep the company compliant (GCP/GLP)
- Build, mentor and scale the regulatory team as the pipeline advances
ESSENTIAL REQUIREMENTS FOR ROLE
- Advanced degree with 12+ years in regulatory affairs, or a Bachelor's degree with 15+ years; PhD or PharmD preferred
- Proven record leading submissions and direct FDA interactions
- Oncology regulatory experience strongly preferred
- Strong working knowledge of FDA, EMA and ICH guidelines
- Experience managing direct reports and leading cross-functional teams
- Strategic mindset paired with willingness to roll up your sleeves
- Excellent communication, negotiation and project management skills
Please send me a message or email at sydney.hewitt@epmscientific.com if you'd like to discuss further!
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