Director, Regulatory Affairs

Formation Bio•Boston, MA

4h•$235,000 - $300,000•Hybrid

About The Position

The Director, Regulatory Affairs is responsible for developing and executing regional regulatory strategies, objectives, and plans to support the development and commercialization of Formation Bio’s assets. This role provides regulatory leadership for global registration and lifecycle management activities and drives regulatory strategy for programs that are currently US-focused, with potential for global expansion, partnering cross-functionally to ensure aligned and timely execution.

Requirements

BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience.
Has 10+ years of Regulatory Affairs experience and/or additional experience in other functions of biotechnology organizations.
Broad regulatory experience with a focus on global regulatory affairs strategy (this can be across a breadth of development, including clinical, non-clinical and CMC aspects of drug development, and across regions such as US and EU).
Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s).
Ability to read, analyze and interpret scientific and technical information and regulatory documents.
Ability to present complex issues in oral and written form
Experienced in responding to inquiries from HAs. (EMA & FDA)
Extensive experience with biologics and/or small molecule

Responsibilities

Leads the development and execution of regulatory strategies to obtain and maintain investigational and marketing applications and support lifecycle management activities.
Provides regulatory guidance to cross-functional teams based on technical and regulatory knowledge, supporting the development of strategic and tactical plans and identifying regulatory risks associated with product development.
Represents Regulatory on asset development teams, ensuring alignment of regulatory plans with overall program objectives.
Leads the preparation, coordination, and submission of regulatory documents (e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental applications and other relevant filings) in alignment with agreed regulatory strategy and in partnership with Reg Ops
May provide regulatory CMC input to support drug development and manufacturing/supply activities.
Lead and support interactions with Health Authorities, including preparation of briefing materials, meeting leadership, and follow-up activities, and serve as regulatory contact for assigned programs.
Partners with internal stakeholders to promote compliance with applicable regulatory requirements and company policies.
Maintains awareness of evolving regulations and guidance; communicates relevant updates to cross-functional teams and collaborates with regulatory policy/intelligence colleagues as appropriate.
Contributes to the development and continuous improvement of regulatory processes and departmental operating procedures.
Applies strong knowledge of regulatory principles and business objectives to support program-level decision-making and drive effective cross-functional collaboration.