Director, Regulatory Affairs

About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.

You can read more at the following links:

• Our Vision for AI in Pharma

• Our Current Drug Portfolio

• Our Technology & Platform

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

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.

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.

About You

• 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

Formation Bio is prioritizing hiring in key hubs, primarily the Boston and New York City metro area. These positions will follow a hybrid work model with 1-3 days required at the office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please only apply if you reside in these locations or are willing to relocate.

Compensation Range: $235,000 - $300,000

Salary ranges are informed by a number of factors including geographic location. The range provided includes base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range doesn't match your expectations, please still apply because we may have something else for you.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.