Associate Director, Regulatory Affairs

Role: Senior Regulatory Affairs professional supporting development and commercialization of oncology assets at Nuvation Bio. Responsibilities: lead regulatory strategy, prepare and submit INDs, NDAs, DMFs, and other filings; manage interactions with US FDA and international regulatory agencies; contribute to pharmacovigilance and ensure compliance with regulations. Requirements: Bachelor’s or Master’s degree, 10+ years in drug development/regulatory affairs within biopharma; strong experience with US FDA regulations, regulatory submissions, eCTD; NDA experience preferred; familiarity with global clinical study support. High-Value: oncology, drug development, IND/NDA submissions, regulatory strategy, US and international filings, experience supporting clinical development phases. WorkSetup: based in Boston area preferred; travel up to 10% domestically and internationally.