Hiring: Executive Director, Regulatory Strategy Company: Exelixis Location: Alameda, CA Job Posted Time: 2026-09-10 11:46:31 Target Skills & Keywords : Regulatory Compliance About the job Experience: •Minimum 18 years pharmaceutical industry and/or regulatory agency experience or the equivalent combination of experience and education/training •Minimum nine years regulatory experience in a position of substantial responsibility. •Prior experience working with the relevant review divisions at FDA. •Has extensive experience in relevant industry/profession. Required Skills: •Oversight and management of Regulatory Program Leaders and their staff. •Oversee the development of plans incorporating regulatory strategies designed to maximize chances of successful registration. •Understand policies, key personnel, and regulatory climate at the FDA and maintain a good working relationship with the FDA. •Oversight of documents submitted to regulatory agencies to assure that they are complete, well organized, are of high-quality, are in regulatory compliance, and are presented in a way that facilitates agency review. •Address regulatory agency requirements to pursue approval of additional clinical indications and new dosage forms. •Manage clinical development program planning to anticipate changes in regulatory environment and approval requirements. •Oversee Exelixis interactions with Health Authorities. Ensure there is to expedient and efficient review and approval of submissions by the regulatory program teams. •Ensure the preparation and submission of INDs, NDAs, BLAs, reports and correspondence to regulatory agencies are completed by the team according to Exelixis best practice and of high quality. Qualifications: •BS/BA degree in related discipline and a minimum of 18 years of related experience; or, MS/MA degree in related discipline and a minimum of 16 years of related experience; or, PhD in related discipline and a minimum of 15 years of related experience; or, Equivalent combination of education and experience. •May require certification in assigned area. Compensation: •$268,500 - $380,000 / 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!