Executive Director, Worldwide Operations Office - Pharmacovigilance in Cambridge

Regeneron is seeking an Executive Director, Worldwide Operations Office to join our PV Organization! The Executive Director, Worldwide Operations Office serves as the single point of accountability for Regeneron’s global-to-local pharmacovigilance model. This role ensures consistency, compliance and operational excellence across all regions and countries by defining the scope and governance of regional PV Hubs, establishing clear boundaries between global, regional, and local responsibilities, and translating regional insights into strategic guidance for GPS leadership. This role drives a unified, patient-centered approach to safety across Regeneron’s global footprint while enabling appropriate local adaptation to meet regional regulatory requirements.

Responsibilities

• Partner with cross‑functional US and International teams to embed a patient safety mindset across Regeneron’s global operations (e.g., gather feedback from regional leaders, establish knowledge sharing forums).
• Provide functional oversight of WWOO and regional PV Hubs, ensuring operational performance, quality standards, regulatory compliance, and consistent application of global processes across markets.
• Define execution scope for regional PV Hubs, determining which processes require localization to meet requirements versus which can be executed through centralized global processes, including clear delineation of responsibilities between GPS and affiliate teams.
• Establish governance framework for local process adaptation, defining clear standards for when and how global PV processes may be tailored to meet local regulatory requirements.
• Develop innovative approaches to delivering on core activities that integrate new technologies, including AI.
• Aggregate insights and potential risks from regional and country‑level activities to shape, influence, and prioritise objectives for the PV system.
• Coordinate across key GPS functions (e.g., QPPV, Case Management, Quality & Compliance) on matrixed activities, regional priorities, and global‑to‑local interdependencies.
• Adapt the international model to fit changing business needs, including assessing future needs for additional PV Hubs based on portfolio expansion, geographic growth, and regulatory landscape changes.
• Build, coach, and scale a high‑performing team, and drive succession planning and talent pipelines.
• Lead talent strategy and leadership development initiatives that raise capabilities across the organization.
• Influence cross‑functional leaders to align priorities and drive enterprise results.

Qualifications

• Advanced degree (PharmD, MD, MS, or MBA) in life sciences, healthcare, or related field preferred; Bachelor's degree required.
• 17+ years of experience in pharmacovigilance, international operations within the life sciences industry.
• Minimum 7 years in leadership roles with demonstrated experience managing international or multi‑regional operations.
• Proven ability to develop relationships and influence key decision making with GPS and Non‑GPS functions (e.g., QPPV, Med Affairs, Regulatory), regions, and senior stakeholders.
• Strong background in PV compliance, inspection readiness, and quality oversight across multiple markets.
• Strategic mindset with the ability to translate regional complexity into clear governance, decisions, and executive‑level insights.
• Preferred experience with AI technologies.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.