Senior Director, Regulatory Affairs Policy, Regulatory Intelligence & Compliance

Job description

SUMMARY/JOB PURPOSE (Basic purpose of the job): This role provides leadership and strategic oversight for Regulatory Policy & Regulatory Intelligence, and Quality, Standards, and Training (GPS & RA only) at Exelixis. The position oversees the surveillance, triage, interpretation, and dissemination of global regulatory intelligence across Research & Development (R&D), Quality (QA), Information Technology (IT) and Pharmaceutical Supply Chain (PSC), partnering with cross-functional subject matter experts to ensure impact assessments are conducted and documented. The role is also responsible for oversight of procedures, compliance activities, training, and inspection and audit readiness for the GPS & RA organization. ESSENTIAL DUTIES/RESPONSIBILITIES: Serve as the business owner for the end-to-end regulatory intelligence process across R&D, QA, IT, and PSC. Set strategic direction and priorities for the Regulatory Policy and Intelligence team, ensuring alignment with organizational goals and a proactive approach to assessing impact and communicating regulatory risks and opportunities relevant to Exelixis. Leverage strong persuasion and influencing skills to drive alignment and adoption...