Senior Director Regulatory Strategy

Senior Director, Regulatory AffairsLocation: Northern NJ / Greater NYC Metro (Hybrid - minimum 3 days onsite) Job Type: Full-Time, Permanent Industry: Biotechnology / PharmaceuticalsAbout the OpportunityWe 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 ResponsibilitiesBuild and execute regulatory strategy supporting product development, approval, and commercializationLead preparation and submission of key regulatory filings (IND, NDA, MAA)Act as the strategic regulatory partner across R&D, Clinical Development, and Quality AssuranceMonitor evolving FDA and international regulatory requirements to ensure ongoing compliance (GCP/GLP)Identify regulatory risk early and drive proactive mitigation strategiesQualificationsAdvanced degree with 12+ years of experience, or Bachelor's degree with 15+ years in regulatory affairsStrong working knowledge of FDA and international regulatory frameworksTrack record leading regulatory submissions and cross-functional teamsExcellent communication, negotiation, and project management skillsComfortable operating in a fast-paced, high-growth environmentHow to ApplyInterested candidates are welcome to reach out directly for a confidential conversation.