Regeneron

Associate Director, Risk Management – Center of Excellence Operations

RiskRiskFull TimeRemoteSeniorTeam 10,001+Since 1988H1B SponsorCompany Site LinkedIn

Location

United States

Posted

26 days ago

Salary

$176.1K - $287.3K / year

Seniority

Senior

Bachelor Degree10 yrs expEnglishPMP

Job Description

• 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 across 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

Job Requirements

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 decisions and ability to work through ambiguity
Demonstrated achievements of increasing complexity/responsibility
Must be proficient in Project Management tools (e.g. MS Project, SharePoint)
Proven ability to multi-task, think critically, prioritize and manage multiple priorities and drive change in dynamic, fast-paced environments
Strong meeting facilitation skills
Excellent time-management skills

Benefits

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)