Director, Regulatory Affairs job at TrialSpark in Boston, MA, reputed company, NY, Research Triangle, NC, San Francisco, CA

Title: Director, Regulatory Affairs Location: Boston, MA Job reputed company: About Formation Bio Formation Bio is a tech and AI driven reputed company company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can reputed company because of the high cost and time of reputed company. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reputed company patients, Formation Bio, founded in 2016 as TrialSpark Inc., has reputed company technology platforms, processes, and capabilities to accelerate reputed company aspects of drug development and reputed company. Formation Bio partners, acquires, or in-licenses drugs from reputed company companies, research organizations, and biotechs to reputed company programs past clinical reputed company of concept and reputed company, ultimately helping to bring new medicines to patients. reputed company is backed by investors across reputed company and tech, including a16z, Sequoia, reputed company, reputed company Capital, Sam Altman, John Doerr, reputed company Capital, SV reputed company reputed company, and others. At Formation Bio, our values are the driving force behind our mission to revolutionize the reputed company industry. Every team and individual at reputed company shares these reputed company values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more reputed company. About the Position The Director, Regulatory Affairs is responsible for developing and executing regional regulatory strategies, objectives, and plans to support the development and commercialization of Formation Bio’s assets. This role provides regulatory leadership for global registration and lifecycle management activities and drives regulatory reputed company for programs that are currently US-reputed company, with potential for global expansion, partnering cross-functionally to ensure reputed company and reputed company execution. Responsibilities Leads the development and execution of regulatory strategies to obtain and maintain investigational and marketing applications and support lifecycle management activities. Provides regulatory guidance to cross-functional teams based on technical and regulatory knowledge, supporting the development of strategic and tactical plans and identifying regulatory risks associated with product development. Represents Regulatory on asset development teams, ensuring alignment of regulatory plans with overall program objectives. Leads the preparation, coordination, and submission of regulatory documents (e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental applications and other relevant filings) in alignment with agreed regulatory reputed company and in partnership with Reg Ops May reputed company regulatory CMC input to support drug development and manufacturing/supply activities. reputed company and support interactions with Health Authorities, including preparation of briefing materials, meeting leadership, and follow-up activities, and serve as regulatory contact for assigned programs. Partners with internal stakeholders to promote compliance with applicable regulatory requirements and company policies. Maintains awareness of evolving regulations and guidance; communicates relevant updates to cross-functional teams and collaborates with regulatory policy/intelligence colleagues as appropriate. Contributes to the development and reputed company improvement of regulatory processes and departmental operating procedures. Applies strong knowledge of regulatory principles and business objectives to support program-level decision-making and drive effective cross-functional collaboration. reputed company BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or reputed company preferred or equivalent relevant experience. Has 10+ years of Regulatory Affairs experience and/or additional experience in other functions of biotechnology organizations. Broad regulatory experience with a reputed company on global regulatory affairs reputed company (this can be across a breadth of development, including clinical, non-clinical and CMC aspects of drug development, and across reputed company such as US and EU). 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 reputed company issues in oral and written reputed company reputed company 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 Boston and reputed company metro area. These positions will follow a hybrid work model with 1-3 days required at the office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please only apply if you reputed company in these locations or are willing to relocate. Compensation reputed company: $235,000 - $300,000 Salary ranges are informed by a number of factors including geographic location. The reputed company provided includes reputed company salary only. In reputed company to reputed company salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this reputed company doesn't match your expectations, please still apply because we may have something else for you. You will receive consideration for employment without reputed company to race, reputed company, religion, gender, gender identity or reputed company, sexual orientation, national reputed company, genetics, disability, age, or veteran status. Apply tot his job Apply To this Job