Hiring: Associate Regulatory Affairs Strategy Director (Oncology) Company: Exelixis Location: Alameda, CA Job Posted Time: 2026-09-16 11:46:32 About the job Required Skills: •Interact directly with regulatory authorities. •Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams. Provide risk assessments and recommendations for various regulatory scenarios, including possible expedited pathways. •Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs. •Interface directly with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions. •Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and regulatory strategy. •Coordinate, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations. •Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs. •Lead multiple assets and/or studies as assigned. Qualifications: •Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/ DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA). •Bachelor’s degree in related discipline and a minimum of eleven years of related experience; or, Master’s degree in related discipline and a minimum of nine years of related experience; or, PhD degree in related discipline and a minimum of five years of related experience; or, Equivalent combination of education and experience. Compensation: •$195,000 - $277,500 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!