Senior Director, Regulatory Affairs - Client-Dedicated Embedded Role

Thermo Fisher Scientific seeks an experienced Senior Director of Regulatory Affairs to lead regulatory strategy for a client-dedicated embedded role within a clinical-stage biotechnology company developing RNA-based therapeutics. This position requires strategic oversight of clinical and preclinical programs, health authority interactions, and regulatory submissions in an entrepreneurial environment.

Responsibilities

• Serve as senior regulatory lead embedded within client organization, providing strategic and operational regulatory oversight
• Develop and execute global regulatory strategies integrating clinical, nonclinical, CMC, and product development objectives
• Lead health authority interactions with FDA, EMA, TGA, and other regulatory agencies
• Prepare briefing packages, meeting requests, regulatory submissions, and post-meeting follow-up documentation
• Partner with cross-functional teams to ensure study designs and data packages support regulatory interactions and submissions

Requirements

• Bachelor's degree in scientific, medical, pharmaceutical, or related discipline; advanced degree preferred
• 15+ years progressive regulatory affairs experience in biotechnology or pharmaceutical industry
• Extensive experience developing global regulatory strategies from early development through registration
• Demonstrated expertise with INDs, CTAs, and major global regulatory submissions
• Strong oncology drug development experience required or strongly preferred
• Experience with advanced or novel therapeutic modalities