BioSpace
Join to apply for the
Senior Director, Regulatory Affairs
role at
BioSpace
3 days ago Be among the first 25 applicants
About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Founded in 2016 as TrialSpark Inc., the company builds 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 such as a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.
The Position The Senior Director, Regulatory Affairs lead is responsible for developing and directing the regional regulatory strategy, objectives, policies, and programs pertaining to the development and marketing of Formation Bio’s assets. This role includes lead regulatory responsibility for support of global registration, life cycle support, and the leadership of regulatory strategy for projects that are currently US focused with potential global extension, 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 toward 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 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 agencies to develop effective professional relationships and a positive company image.
Provides guidance to all appropriate departments to assure compliance with applicable regulations.
Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel, and works with regulatory policy and intelligence.
Provides recommendations for regulatory department operating procedures.
Actively trains and mentors junior staff; provides broader guidance on regulatory interpretation to Formation Bio’s staff.
About You
BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience.
10-20 years of Regulatory Affairs experience, including experience in other biopharmaceutical areas. Broad experience across the life cycle of pharmaceutical products—including clinical, non‑clinical, and CMC aspects—and across main regions such as US and EU.
Strong competency in understanding regulatory requirements and the emerging regulatory landscape associated with health authorities.
Ability to read, analyze, and interpret scientific and technical information and regulatory documents.
Ability to present complex issues both orally and in written form.
Experienced in responding to inquiries from health authorities (EMA & FDA).
Extensive experience with biologics and/or small molecules.
Location & Relocation 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.
Compensation The target salary range for this role is: $300,000 - $350,000. Salary ranges are informed by geographic location and include base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range does not 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.
Job Details
Seniority level: Director
Employment type: Full‑time
Job function: Legal
#J-18808-Ljbffr
Senior Director, Regulatory Affairs
role at
BioSpace
3 days ago Be among the first 25 applicants
About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Founded in 2016 as TrialSpark Inc., the company builds 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 such as a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.
The Position The Senior Director, Regulatory Affairs lead is responsible for developing and directing the regional regulatory strategy, objectives, policies, and programs pertaining to the development and marketing of Formation Bio’s assets. This role includes lead regulatory responsibility for support of global registration, life cycle support, and the leadership of regulatory strategy for projects that are currently US focused with potential global extension, 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 toward 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 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 agencies to develop effective professional relationships and a positive company image.
Provides guidance to all appropriate departments to assure compliance with applicable regulations.
Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel, and works with regulatory policy and intelligence.
Provides recommendations for regulatory department operating procedures.
Actively trains and mentors junior staff; provides broader guidance on regulatory interpretation to Formation Bio’s staff.
About You
BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience.
10-20 years of Regulatory Affairs experience, including experience in other biopharmaceutical areas. Broad experience across the life cycle of pharmaceutical products—including clinical, non‑clinical, and CMC aspects—and across main regions such as US and EU.
Strong competency in understanding regulatory requirements and the emerging regulatory landscape associated with health authorities.
Ability to read, analyze, and interpret scientific and technical information and regulatory documents.
Ability to present complex issues both orally and in written form.
Experienced in responding to inquiries from health authorities (EMA & FDA).
Extensive experience with biologics and/or small molecules.
Location & Relocation 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.
Compensation The target salary range for this role is: $300,000 - $350,000. Salary ranges are informed by geographic location and include base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range does not 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.
Job Details
Seniority level: Director
Employment type: Full‑time
Job function: Legal
#J-18808-Ljbffr