Senior Director, Regulatory Affairs Policy, Regulatory Intelligence & Compliance

Exelixis•Alameda, CA

1d•Onsite

About The Position

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.

Requirements

BA/BA degree in related discipline and 15 years of related experience; or, MA/MA degree in related discipline and 13 years of related experience; or, PhD in related discipline and 12 years of related experience; or, Equivalent combination of education and experience.
Develops and manages plans, establishes timelines, sets standards for performance.
Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results.
Takes pride in delivering high quality work.
Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work.
Demonstrates clear and effective verbal and written communication.
Provides timely and appropriate information updates.
Speaks clearly and confidently in one-to-one situations and effectively presents information to cross-functional groups of colleagues.
Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.
Manages effectively performing teams, facilitates team alignment and achievement of common objectives.
Engages internal and external stakeholders to establish productive collaborative relationships.
Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve problems.
Provides regulatory expertise to cross-functional teams.
Understands longer term consequences of decisions and actions.
Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives that contribute to departmental goals.
Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility.
Plans and executes multiple activities.
Considers alternative methods and contingency plans to avoid potential issues.
Designs and implements solutions to address project level challenges, taking into consideration the broader impact.

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 of proactive regulatory intelligence priorities across senior management and key stakeholders.
Establish and govern a regulatory surveillance framework, driving cross‑functional collaboration to document impact assessments and action plans from new regulatory intelligence.
Establish and leverage regulatory intelligence networks that support proactive compliance monitoring and inspection readiness.
Responsible for overseeing and executing regulatory compliance and inspection‑readiness strategy for the GPS & RA functions and outsourced services.
Partner with Quality during Health Authority inspections and audits.
Oversee procedural framework within GPS & RA, ensuring procedures are developed and periodically reviewed in alignment with regulatory and Exelixis requirements.
Responsible for oversight of GPS & RA compliance activities, CAPAs, Quality Events, and Effectiveness Checks.
Provide oversight of pharmacovigilance or safety data exchange agreements with business partners and vendors to outline specific obligations for safety data exchange and reporting.
Provide strategic input to clinical study activities including CRO Regulatory Affairs Management Plans (RAMPs), Safety Management Plans (SMPs), and ensure ongoing oversight and compliance of Trial Master File (TMF) maintenance.
Provide oversight of training compliance for GPS & RA, vendors, and contracted staff as applicable.
Lead a high-performing team, fostering a culture of innovation, collaboration, and continuous improvement.