Regulatory Affairs Principal, Pharmaceutical and Combination Products

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic regulatory leadership to facilitate the development, approval, and lifecycle management of pharmaceutical and combination drug-device products.

• Act as a vital regulatory partner to cross-functional teams, primarily focusing on FDA CDER interactions, IND/NDA submissions, and global regulatory strategy.

• Author and review INDs, NDAs, supplements, and various global regulatory submissions.

• Create and present high-quality briefing documents, responses, and regulatory communications.

• Offer regulatory guidance on clinical, nonclinical, and CMC development activities.

• Drive the regulatory strategy for combination products, including coordination with FDA’s Office of Combination Products (OCP).

• Provide advice on labeling strategy, encompassing prescribing information and device components of combination products.

• Evaluate the regulatory impact of development and post-approval changes and outline suitable regulatory pathways.

• Support global regulatory initiatives, including submissions and interactions with international health authorities (e.g., EMA).

• Keep abreast of evolving regulatory requirements and convert them into actionable guidance for teams.

• Mentor and offer guidance to junior regulatory team members.

⛳️ Requirements

• Over 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 in interacting with FDA, including preparation for meetings and executing regulatory strategies.

• Experience with combination products (drug-device) is strongly preferred.

• Solid understanding of U.S. regulatory requirements (21 CFR 210/211, Part 4) and relevant FDA guidance.

• Exposure to global regulatory environments (e.g., EMA, ICH) is preferred.

• A bachelor's degree in a scientific discipline is required.

• An advanced degree (MS, PhD, PharmD) is preferred.

• Certification RAC (US or Drugs) is preferred.

• Willingness to travel 0-10% of the time.

🏝️ Benefits

• Competitive salary.

• Flexible working hours.

• Professional development budget.

• Home office setup allowance.

• Global team events.