Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

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.

The Senior Director, Regulatory Affairs lead is responsible for developing and directing the regional regulatory strategy, objectives, policies, and programs pertaining to developing and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global registration and life cycle support and the leadership of regulatory strategy for projects that are currently US focused, but potentially will extend globally, coordinating departmental and cross-functional support.

Responsibilities

• Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations.
• Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identifies and assesses regulatory risks associated with product development for Formation Bio's drug assets.
• Represents the Regulatory function on asset development teams
• Leads the development of strategic plans and tactical implementation resulting in the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
• Provides Regulatory CMC guidance around drug development and manufacturing/supply processes
• Understands, interprets and advises on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of biopharmaceutical products in support of CMC applications
• Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
• Provides guidance to all appropriate departments in Formation Bio to assure compliance with applicable regulations.
• Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel.
• Makes recommendations for regulatory department operating procedures.
• Actively trains/mentors' junior staff; provides broader guidance on regulatory interpretation to Formation Bio's staff.
• Consistently works with abstract ideas or situations across functional areas of the business. Through assessment of intangible variables, identifies and evaluates fundamental issues providing strategy and directions for major functional areas. Requires in-depth knowledge of the functional area, business strategies, and the company's goals.

About You

• BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience.
• Has 10-20 years of Regulatory Affairs experience as well as additional experience in the biopharmaceutical industry in other areas. The regulatory experience should be broad (across the life cycle of pharmaceutical products, including clinical, non-clinical and CMC aspects of drug development, and across main regions such as US and EU) to ensure appropriate leadership
• 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 New York City and Boston metro areas, with additional growth in the Research Triangle (NC) and San Francisco Bay Area. Please only apply if you reside in these locations or are willing to relocate.

The target salary range for this role is: $300,000 - $350,000. 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.