Senior Manager, Regulatory Operations Systems Veeva RIM Product Owner

Madrigal Pharmaceuticals • Conshohocken, PA

14d • $141,000 - $172,000 • Onsite

About The Position

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. About the Role: Lead the vision, development and lifecycle management of the global RIM platform ensuring alignment with evolving regulatory, business and user needs. Act as the critical link between business and technology, translating complex requirements into scalable solutions that support timely, compliant and high-quality regulatory submissions. Champion system adoption, innovation, and data integrity, driving operational excellence and continuous improvement through cross-functional collaboration and governance across the regulatory lifecycle.

Requirements

• Bachelor’s degree or equivalent experience.
• 7–10 years of experience in Regulatory Systems, RIM operations, validated systems delivery, or GxP release/change management.
• Strong experience with Veeva Vault RIM (preferred) and regulated change governance.
• Demonstrated success leading cross-functional releases and/or projects and complex stakeholder alignment.
• Strong communication planning, stakeholder engagement, and change adoption skills.
• Execution discipline, high accountability, structured thinking.

Nice To Haves

• Experience with adjacent RA ecosystem components (publishing interfaces, labeling, IDMP/SPOR readiness, integrations).
• Familiarity with risk-based validation approaches and deployment governance.
• Experience leading global rollouts or multi-region adoption programs.
• Influencing without authority across RA, IT, QA, and vendors.

Responsibilities

• RIM Strategy & Roadmap Ownership Define and maintain the product vision, and multi‑year roadmap for the RIM platform in close alignment with IT and with Regulatory strategy. Contribute to Regulatory Systems vision and strategy sess technology opportunities, platform capabilities, and dependencies.
• RIM Backlog & Release Management Prioritize and manage the product backlog based on value, risk, and regulatory deadlines. Collaborate with architects and vendors to ensure proposed features and changes are compliant, scalable, and integrated. Establish release schedule and coordinate releases in close collaboration with IT, ensuring readiness of testing, training, communication and documentation. Drive user adoption, and continuous improvement feedback loops.
• Compliance & Validation Ownership Ensure that the system maintains regulatory (GxP, 21 CFR Part 11, Annex 11) and quality compliance. Participate in change control, risk assessments, validation strategy, and audit responses. Partner with QA/CSV to ensure proper documentation and traceability.
• Stakeholder Management & Change Management Serve as the primary point of contact for Regulatory Affairs, Regulatory Operations, Quality, and other stakeholders regarding RIM capabilities. Facilitate governance forums. Communicate system changes, benefits, and impact clearly across the organization. Own communication channels to Key Users and End Users (incl. End User community). Own RIM training approach and ensure training assets are updated with Key Users and Business Admin.
• Operational Performance Establish and track Operational Performance KPIs and drive continuous improvement based on metrics and feedback.

Benefits

• All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create.
• By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.
• Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.
• We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings.
• In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family.
• The company also provides other benefits in accordance with applicable federal, state, and local laws.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level