Director Regulatory Affairs - Clinical Strategy
Director Regulatory Affairs Strategy | Raleigh, NC (Hybrid)
A growing, specialty pharmaceutical company is seeking a senior regulatory leader to drive clinical regulatory strategy across a diverse portfolio of marketed and pipeline assets.
This is a high-impact, highly visible role working at the intersection of clinical development and regulatory strategy. You'll partner cross-functionally with senior leadership to shape development strategies, support lifecycle initiatives, and guide regulatory pathways for differentiated pharmaceutical products. If you enjoy translating complex clinical data into clear regulatory strategy-and want to operate in a fast-moving, asset-driven environment-this is a strong opportunity to step into a strategic leadership role.
What you'll be doing:
- Leading clinical regulatory strategy across development and lifecycle programs, including 505(b)(2) pathways
- Serving as a key advisor on regulatory and clinical strategy to support pipeline expansion and due diligence activities
- Designing and executing regulatory strategies incorporating approaches such as bridging, RWE/RWD, and MIDD
- Leading preparation and review of clinical sections for IND and NDA submissions as well as module 2 documents.
- Driving FDA and Health Authority interactions
- Evaluating clinical data to inform regulatory positioning and risk mitigation
- Collaborating closely with Clinical Development, Medical Affairs, and Commercial teams to align strategy
- Mentoring and guiding internal regulatory team members on clinical strategy and execution
Qualifications:
- 10+ years in Regulatory Affairs within pharmaceutical or biotech environments
- Strong experience in clinical and non clinical regulatory strategy (not just operations or publishing)
- Demonstrated experience supporting or leading IND, and NDA submissions
- Strong writer - Module 2
- Direct experience with FDA interactions and regulatory strategy development
- Experience with 505(b)(2) pathways, lifecycle management, or reformulation strategies
- Ability to work cross-functionally and influence without direct authority in a fast-paced environment
- Preferred: orphan drug designations and pediatric study plans
- Advanced degree preferred (PharmD, PhD, MD, or equivalent scientific background)
Location: Raleigh, NC- hybrid, 3 days in office. Must be local or willing to relocate.
Compensation: $200,000-230,000
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