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)(1) pathways and 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)(1) pathways and 505(b)(2) pathways , lifecycle management, or reformulation strategies Ability to work cross-functionally and influence without direct authority in a fast-paced environment 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. #J-18808-Ljbffr EPM Scientific