Associate Manager, Regulatory Affairs Strategy - Oncology

Role: Associate Manager, Regulatory Affairs (Oncology) supporting global regulatory submissions and strategies for innovative cancer therapeutics. Responsibilities: coordinate preparation, submission, and maintenance of oncology-related dossiers such as INDs, CTAs, Orphan drug applications, and Annual Reports; assist with agency meetings and briefing documents; manage agency queries and commitments; participate in cross-functional development activities; research and support regulatory strategy development; stay current on regulations. Requirements: MD, PhD, or PharmD with industry or post-doctoral experience; oncology experience preferred; solid knowledge of FDA and international drug regulations, guidance, and development processes; experience managing CRO interactions for clinical trials outside the US/EU; strong organizational, communication, and collaboration skills; proficiency in English. High-Value: Oncology therapeutic area, clinical and preclinical development stages, global regulatory submissions, agency interactions, and cross-functional collaboration. Work setup: On-site 4 days/week in Tarrytown, NY or Warren, NJ.