Regulatory Affairs Director

Director, Regulatory Affairs - Permanent - Boston, MA

Proclinical is seeking a Director, Regulatory Affairs for a mid-sized oncology focused biotechnology company with their site in Massachusetts.

Primary Responsibilities:

In this role, you will have the opportunity to define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the global regulatory lead on relevant project teams to formulate and execute development strategies for developmental programs. You will be the primary contact to interface with FDA and will lead cross-functional teams to deliver domestic and international regulatory submissions including IND, CTA, NDA and MAA submissions. You will be coaching and mentoring junior regulatory staff to support their development and enable program deliverables.

The position will be based at their Massachusetts site in a hybrid work schedule.

Skills & Requirements:

• You have earned your B.S and/or M.S. and bring at least 5 years of increasing responsibility in regulatory affairs. Advanced degree or education in a scientific field is a plus.
• You are results-oriented and have comprehensive knowledge of the drug development process and have a demonstrated record of successful regulatory submissions (IND, CTA, NDA/MAA, etc.)
• Experience in precision oncology, rare disease and/or companion diagnostic (CDx) is a plus.

The Director, Regulatory Affairs will:

• Report to our Head of Regulatory Affairs and work side by side with your R&D colleagues to develop and execute innovative regulatory strategies for their development programs (from FIH through late-stage clinical programs), including the implementation of non-clinical and clinical regulatory strategy for relevant products.
• Lead the preparation and submission of high quality domestic and global regulatory submission documents (i.e. IND, CTA, NDA/MAA), as well as leading the development of response strategies to regulators.
• Communicate with the global regulatory authorities and leading the preparation and conduct of meetings with health authorities, which includes the development of robust briefing packages and comprehensive meeting preparation to maximize outcomes of meetings.
• Lead and mentor junior staff in the regulatory team to support their development and enable program deliverables.

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at ( 1) 646-779-7961 or p.huynh@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.