Senior Director - Regulatory Affairs Policy, Intelligence & Compliance

1w1 week ago

Exelixis

US · Full-time · $275,000 – $425,000

About this role

This role provides leadership and strategic oversight for Regulatory Policy & Regulatory Intelligence, and Quality, Standards, and Training (GPS & RA only) at Exelixis. It oversees surveillance, triage, interpretation, and dissemination of global regulatory intelligence across R&D, QA, IT, and PSC. Cross-functional partnerships ensure impact assessments are conducted and documented.

Serve as business owner for the end-to-end regulatory intelligence process. Set strategic direction and priorities for the team, aligning with organizational goals. Drive cross-functional collaboration to document impact assessments and action plans from new intelligence.

Oversee regulatory compliance, inspection-readiness strategy for GPS & RA functions and outsourced services. Partner with Quality during Health Authority inspections and audits. Lead procedural framework development and periodic reviews aligned with requirements.

Provide oversight of compliance activities, CAPAs, Quality Events, and training for GPS & RA, vendors, and staff. Lead a high-performing team fostering innovation, collaboration, and continuous improvement. Leverage networks for proactive compliance monitoring.

Requirements

BA/BS degree in related discipline and 15 years of related experience; or MA/MS degree and 13 years; or PhD and 12 years; or equivalent
Develops and manages plans, establishes timelines, sets standards for performance
Proactively balances commitments and overcomes challenges to achieve results
Takes pride in delivering high quality work
Applies extensive knowledge of the regulatory framework, industry drivers and practices
Develops innovative approaches to regulatory challenges
Strong persuasion and influencing skills for stakeholder alignment

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
Leverage persuasion and influencing skills to drive alignment across senior management and stakeholders
Establish and govern a regulatory surveillance framework with cross-functional impact assessments
Establish regulatory intelligence networks supporting compliance monitoring and inspection readiness
Oversee regulatory compliance and inspection-readiness strategy for GPS & RA functions
Oversee procedural framework, compliance activities, CAPAs, Quality Events, and training
Lead a high-performing team fostering innovation, collaboration, and continuous improvement