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 crucial regulatory collaborator with cross-functional teams, primarily focusing on FDA CDER interactions, IND/NDA submissions, and global regulatory strategies.

• 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 initiatives.

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

• Advise on labeling strategies, covering prescribing information and device components of combination products.

• Evaluate the regulatory impact of development and post-approval modifications, establishing suitable regulatory pathways.

• Support global regulatory operations, including submissions and interactions with non-U.S. health authorities (e.g., EMA).

• Remain updated on evolving regulatory requirements and convert them into actionable guidance for teams.

• Mentor and guide junior members of the regulatory team.

⛳️ Requirements

• Over 7 years of regulatory affairs experience in pharmaceuticals, biotechnology, or combination products.

• Proven track record with FDA CDER submissions, such as INDs, NDAs, and/or supplements.

• Demonstrated success in engaging with the FDA, including preparation for meetings and execution of regulatory strategies.

• Strong preference for experience with combination products (drug-device).

• Familiarity with U.S. regulatory standards (21 CFR 210/211, Part 4) and applicable FDA guidance.

• Preferred exposure to global regulatory landscapes (e.g., EMA, ICH).

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

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

• RAC certification (US or Drugs) is preferred.

• Willingness to travel 0-10%.

🏝️ Benefits

• Competitive salary.

• Flexible working hours.

• Professional development budget.

• Home office setup allowance.

• Global team events.