The Regulatory Affairs Principal will provide strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products. This individual will 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. This is a high-impact role for a regulatory professional who thrives in a collaborative environment and wants to shape regulatory strategy for innovative combination products. Key Duties Lead and contribute to regulatory strategy for pharmaceutical and combination products across development and lifecycle stages. Author and review IN - Ds, ND - As, 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 IN - Ds, ND - As, 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. Education. Bachelor's degree in a scientific discipline required Advanced degree (MS, PhD, PharmD) preferred. Certifications. RAC (US or Drugs) preferred. Travel 0-10%