Regulatory Affairs Principal, Pharmaceutical and Combination Products

Key Duties

• Lead and contribute to regulatory strategy for pharmaceutical and combination products across development and lifecycle stages
• Author and review INDs, NDAs, supplements, and other global regulatory submissions
• Serve as a primary interface with FDA CDER, including leading preparation for and participation in agency meetings (e.g., Type B/C)
• Develop and deliver high-quality briefing documents, responses, and regulatory communications
• Provide regulatory guidance on clinical, nonclinical, and CMC development activities
• Drive combination product regulatory strategy, including coordination with FDA’s Office of Combination Products (OCP)
• Advise on labeling strategy, including prescribing information and device components of combination products
• Assess regulatory impact of development and post-approval changes and define appropriate regulatory pathways
• Support global regulatory activities, including submissions and interactions with ex-U.S. health authorities (e.g., EMA)
• Stay current on evolving regulatory requirements and translate them into actionable guidance for teams
• Mentor and provide guidance to junior regulatory team members

Qualifications

• Experience 7+ years of regulatory affairs experience in pharmaceuticals, biotechnology, or combination products
• Proven experience with FDA CDER submissions, including INDs, NDAs, and/or supplements
• Demonstrated success interacting with FDA, including meeting preparation and regulatory strategy execution
• Experience with combination products (drug-device) strongly preferred
• Working knowledge of U.S. regulatory requirements (21 CFR 210/211, Part 4) and relevant FDA guidance
• Exposure to global regulatory environments (e.g., EMA, ICH) preferred
• Bachelor’s degree in a scientific discipline required
• Advanced degree (MS, PhD, PharmD) preferred
• RAC (US or Drugs) certification preferred