Director, Risk Management Lead - REMS

Role Summary

Director, Risk Management, leading Global Patient Safety (GPS) risk management operations to deliver pharmacovigilance requirements across Regeneron’s portfolio. The role reports to the Sr. Director, GPS Risk Management and involves driving planning, operations, and processes globally, acting as a REMS planning lead and cross-functional liaison with GPS, Regeneron stakeholders, and PV vendors. It encompasses planning, status reporting, risk and issue management, stakeholder collaboration, development of operational methodologies, and proactive communication on risk management delivery.

Responsibilities

• The Director of GPS Risk Management lead will report directly to the Sr. Director, GPS Risk Management is a key position responsible for assisting in drug safety risk management planning and will drive planning, operations, and processes globally to ensure the successful delivery of risk management pharmacovigilance (PV) requirements of Regeneron’s worldwide portfolio.
• This global role will represent and manage internal and external relationships related to risk management implementation and will work cross-functionally, serving as a key planning REMS lead, working in coordination with all areas of GPS, along with Regeneron stakeholders and pharmacovigilance (PV) vendors.
• The role will be accountable for assisting in all elements of planning, overseeing status reporting, managing risks and issues, collaborating with stakeholders, developing operational methodologies, and proactively communicating with stakeholders on the delivery of Risk Management in support of the portfolio.
• Provide operations for Risk Management planning and pivotal risk management implementation and operations activities globally across the entire product lifecycle for Regeneron medicines and compounds.
• Support the development, execution, and maintenance against the Risk Management strategies (e.g., US REMS, EU risk minimization measures) as determined by GPS stakeholders and provide planning in support of the global portfolio.
• Establish and maintain Risk Management planning and processes to ensure compliance with global regulations related to assessments, working in close collaboration across GPS areas, Regeneron stakeholders and vendors.
• Serve as the liaison between GPS/Regulatory/REMS Operations/Qualified Person for PV Office (QPPVO)/External vendors and cross functional partners, acting as a Global Risk Management ambassador raising awareness of customer/stakeholder needs and dependencies.
• Responsible for leading REMS activities and serve as a point of contact for REMS external vendor.
• Responsible to provide tracking and key performance metrics for GPS.
• Ensure the risk assessment processes are continuously improved to reflect best practices, regulatory trends, and guidelines working across with GPS, and Regeneron stakeholders.
• Serve as the in-house Risk Management operations expert and provide subject matter expertise on the implementation and delivery of risk management programs globally as required.
• Work closely with QPPVO to understand risk management operational needs and support.
• Support and/or participate in Regulatory Agency interactions including audits/inspections.
• Maintain expertise in the regulatory environment, regulations, and requirements for Global Risk Management and REMS activities.
• Other duties as assigned.

Qualifications

• Required: 8+ years' experience in US REMS management operations, including risk management planning and leadership experience in the pharmaceutical industry.
• Required: 5+ years of leading a matrix role and/or EU risk management that encompasses working across all areas of an organization and people management experience.
• Required: Expertise leading large-scale, strategic initiatives related to drug development, risk management/PV operations and global regulatory requirements.
• Minimum Bachelor's Degree; preferred advanced life sciences degree: MPH, PharmD is an advantage.
• Preferred: 5 years of international pharmaceutical activities.
• Strong leadership capabilities and presence, influencing skills, interpersonal, verbal, and written communication skills, organizational and workload planning skills, and the ability to manage multiple projects simultaneously.

Skills

• Cross-functional collaboration and stakeholder management across GPS, Regulatory, REMS Operations, QPPVO, and external vendors.
• Strategic thinking, program management, and the ability to lead large-scale risk management initiatives.

Education

• Bachelor's Degree required; advanced life sciences degree (e.g., MPH, PharmD) preferred.