Senior Director, Regulatory Affairs
About Formation Bio
At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.
At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.
Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.
About the Role
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.
- 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.
- 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.
We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $295,000 - $340,000.
On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.
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.