Formation Bio · 8 hours ago
Senior Director, Regulatory Affairs
New York, NY
Full-time
Hybrid
Director/Executive
$300K/yr - $350K/yr
10+ years expFormation Bio is a tech and AI driven pharma company focused on revolutionizing drug development. The Senior Director, Regulatory Affairs is responsible for developing and directing regulatory strategies, supporting global registration, and leading regulatory projects, ensuring compliance with applicable regulations.
Artificial Intelligence (AI)BiotechnologyClinical TrialsHealth CareMedicalPharmaceutical
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
Qualification
Required
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
Benefits
Equity
Comprehensive benefits
Generous perks
Hybrid flexibility
Company
Formation Bio
Formation Bio is a drug development company that strives to provide treatments to patients faster by reimagining clinical trials.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$528MKey Investors
Andreessen Horowitz
2024-06-26Series D· $372M
2021-09-30Series C· $156M
2018-10-15Series Unknown
Leadership Team
Benjamine Liu
CEO and Co-Founder
Linhao Zhang
Co-Founder and COO
Recent News
Spark Capital
2026-01-07
BioWorld Financial Watch
2025-12-19
2025-12-16
Company data provided by crunchbase