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 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

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

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 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.