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