Senior Director Regulatory Strategy
Senior Director, Regulatory Affairs
Location: Northern NJ / Greater NYC Metro (Hybrid - minimum 3 days onsite) Job Type: Full-Time, Permanent Industry: Biotechnology / Pharmaceuticals
About the Opportunity
We are working with a clinical-stage biotechnology company developing novel treatments for life-threatening diseases, currently seeking a Senior Director of Regulatory Affairs to build and lead regulatory strategy as the organization enters a period of significant growth. This is a rare chance to shape a regulatory function from the ground up and play a foundational role as the team scales.
You'll partner closely with cross-functional leaders across R&D, Clinical Development, and Quality to guide product development and market entry, while owning the regulatory roadmap end to end.
Key Responsibilities
- Build and execute regulatory strategy supporting product development, approval, and commercialization
- Lead preparation and submission of key regulatory filings (IND, NDA, MAA)
- Act as the strategic regulatory partner across R&D, Clinical Development, and Quality Assurance
- Monitor evolving FDA and international regulatory requirements to ensure ongoing compliance (GCP/GLP)
- Identify regulatory risk early and drive proactive mitigation strategies
Qualifications
- Advanced degree with 12+ years of experience, or Bachelor's degree with 15+ years in regulatory affairs
- Strong working knowledge of FDA and international regulatory frameworks
- Track record leading regulatory submissions and cross-functional teams
- Excellent communication, negotiation, and project management skills
- Comfortable operating in a fast-paced, high-growth environment
How to Apply
Interested candidates are welcome to reach out directly for a confidential conversation.
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