Regulatory Affairs Principal, Pharmaceutical and Combination Products

Job Description:

• 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

Requirements:

• 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%

Benefits:

• Competitive salary
• Flexible working hours
• Professional development budget
• Home office setup allowance
• Global team events