Associate Director, Risk Management - Center of Excellence Operations

Regeneron is seeking an Associate Director, Risk Management (Center of Excellence Operations) to join our organization!

In this role, a typical day might include:

This position resides in the Global Patient Safety (GPS) organization of Regeneron and reports into the Risk Management Center of Excellence (RMCoE) functional area and is responsible for driving the strategic and tactical planning and execution needs through the application of organizing resources and knowledge for the team. This position acts as the single point of contact to the RMCoE team in order to meet team and organizational goals by developing, planning, and driving operational efforts.

This role might be for you if you can/have:

• Provides operational oversight in support of the Risk Management Center of Excellence (RMCoE).

• Lead end-to-end planning, coordination, tracking, and timely execution of RMCoE projects from start to finish including operational enhancements, new capabilities, workflow changes, and product-driven initiatives (such as new product indications and regulatory requests).

• Serve as the primary project lead for strategic initiatives, new product launches, finances/budgets/contracts, and cross functional operational improvements.

• Provide structure, planning, and execution support across RMCoE (REMS and aRMMs aross the Regeneron global portfolio.

• Ensure  RMCoE activities and deliverables are clearly communicated between GPS/Regulatory/Qualified Person for PV Office (QPPVO/LPPV)/External vendors and cross functional partners.

• Ensure  RMCoE projects move from concept to delivery with clear timelines and strong coordination and tracking of key deliverables.

• Develop project timelines, charters, requirements, and risk logs, ensuring all stakeholders understand roles, dependencies, and deadlines.

• Lead cross-functional project meetings, drive accountability, and escalate barriers early to maintain project momentum (launch readiness, health authority inspections, new indication launches, and inter-departmental initiatives).

• Identify, design, and implement continuous improvement efforts that strengthen operational efficiency and support the RMCoE

• Lead launch readiness activities to ensure operational alignment across vendors, training, SOP updates, capacity planning, reporting, etc

• Drive and deliver structured project updates, status reports, and risk summaries to leadership and cross-functional partners.

• Conduct post-launch and post project evaluations to identify lessons learned and future improvement opportunities and create Quick Reference and/or Best Practice Guides to facilitate team learnings are captured.

• Manage the preparation of updates for QBRs and senior leadership reviews.

• Establish repeatable project templates and workflows to improve speed, clarity, and consistency.

• Ensure adherence to all relevant processes, trainings, and SOPs.

• Develop and oversee KPIs, dashboards, noncompliance issue resolution, CAPA development and execution, and compliance metrics to measure program and team effectiveness.

To be considered for this opportunity, you must have the following:

• Bachelor’s degree or higher required; advanced degree and/or Project Management Professional (PMP) preferred or equivalent

• A minimum of 10 years of progressive, relevant experience with 5-8 years of progressive experience in strategic project management with a proven record of leading complex, high-impact initiatives within biotech, pharmaceutical, or healthcare organizations is required.

• Proven track record of supporting new product and/or large project launches, vendor management, program implementation, and compliance oversight.

• Demonstrated success in managing external vendors and ensuring adherence to timelines, deliverables, and quality standards.

• Financial acumen with experience managing budgets and strategic oversight of funding

• Experience in Pharmacovigilance/Global Regulatory and/or patient safety preferred

• Knowledge of US and/or international regulatory requirements (REMS and aRMMS preferred

• Excellent written and verbal communication skills; proven ability to work in a matrix organization; established project leadership skills, including problem solving and conflict management

• Proven track record of interpersonal, influencing, leadership, and project management skills

• Ability to enable decision making and assess situations in order to minimize risk, but make timely and pragmatic decis