Regeneron is seeking an Executive Director, Worldwide Operations Office to join our PV Organization!
In this role, a typical day might include:
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, establishes clear boundaries between global, regional, and local responsibilities, and translates 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.
This role might be for you if can:
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 in new technologies, including AI
Aggregate insights and potential risks from regional and country-level activities to shape, influence, and prioritize 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 localinterdependencies
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
To be considered for this opportunity, you must have the following:
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 seniorstakeholders
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
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Executive Director, Worldwide Operations Office - Pharmacovigilance • Uxbridge1
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