Provide strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products
Serve as a key regulatory partner to cross-functional teams, with a primary focus on FDA CDER interactions, IND/NDA submissions, and global regulatory strategy
Author and review INDs, NDAs, supplements, and other global regulatory submissions
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

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
Certification RAC (US or Drugs) preferred
Travel 0-10%

Regulatory Affairs Principal, Pharmaceutical and Combination Products

Key skills