Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

Health and wellness company:
Formation Bio (formerly Trial Spark Inc.). Founded in 2016, the company uses AI‑driven technology to accelerate drug discovery, development, and clinical trials. The organization is based in the New York City and Boston metro areas, with additional opportunities in the Research Triangle (NC) and San Francisco Bay Area.

The Senior Director, Regulatory Affairs leads the development and execution of regulatory strategy, policies, and programs for Formation Bio’s assets. The role provides global registration (primarily US focused with global expansion) and life‑cycle support, coordinating cross‑functional teams and liaising with Health Authority (HA) agencies.

• Design and implement regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations.
• Provide proactive guidance to internal groups on technical and regulatory matters, identifying and assessing regulatory risks associated with product development.
• Represent the regulatory function on asset development teams and lead the creation and submission of regulatory documents (INDs, NDAs/BLAs, CTAs, MAAs, supplemental filings).
• Provide regulatory CMC guidance for drug development, manufacturing, and supply processes.
• Interpret and advise on regulations, guidelines, and policies related to development, registration, and manufacturing of biopharmaceutical products.
• Serve as corporate liaison with regulatory HA agencies to build professional relationships and promote a positive company image.
• Guide all appropriate departments to ensure compliance with applicable regulations.
• Stay current with regulatory guidance, interpret and communicate updates, and work with regulatory policy/intelligence functions.
• Recommend regulatory department operating procedures and mentor junior staff on regulatory interpretation.

• BS, BSc, MS, MSc, PhD, Pharm
  
  D, J.D., or M.D. in science or healthcare (or equivalent experience).
• 10–20 years of regulatory affairs experience across the pharmaceutical life cycle (clinical, non‑clinical, and CMC) and in major regions such as US and EU.
• Strong competency in understanding regulatory requirements and the evolving regulatory landscape.
• Proficiency in reading, analyzing, and interpreting scientific and technical documentation.
• Excellent oral and written communication skills.
• Experience responding to inquiries from HAs (EMA & FDA).
• Extensive experience with biologics and/or small molecules.

Target salary range: $300,000 – $350,000 per annum (base salary only). In addition, the role offers equity, comprehensive benefits, generous perks, hybrid flexibility, and more.

We will consider your application without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Director

Full‑time

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