Senior Manager, Regulatory Operations Systems Veeva RIM Product Owner
Madrigal Pharmaceuticals
2 months ago
Remote friendly (Conshohocken, PA)
United States
$141,000 - $172,000 USD yearly
IT
About The Role
Lead the vision, development, and lifecycle management of the global RIM platform, aligning with evolving regulatory, business, and user needs. Serve as the link between business and technology by 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.
Key Responsibilities
- RIM Strategy & Roadmap Ownership: Define and maintain the product vision and multi-year roadmap in close alignment with IT and Regulatory strategy; contribute to Regulatory Systems vision and strategy; assess 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 features/changes are compliant, scalable, and integrated; establish release schedule and coordinate releases with IT to ensure readiness of testing, training, communication, and documentation; drive user adoption and continuous improvement feedback loops.
- Compliance & Validation Ownership: Ensure 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 for proper documentation and traceability.
- Stakeholder Management & Change Management: 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; own communication channels to Key Users and End Users (including 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.
Qualifications
- 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/projects and aligning complex stakeholders.
- Strong communication planning, stakeholder engagement, and change adoption skills.
- Execution discipline, high accountability, structured thinking.
Preferred Qualifications
- 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.
- Ability to influence without authority across RA, IT, QA, and vendors.
Benefits
- Full-time employees are eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision, life/disability insurance, and 401(k) offerings (traditional, Roth, and employer match, in accordance with applicable plans). Additional voluntary benefits may include supplemental life insurance and legal services; mental health benefits via an Employee Assistance Program.
Application Instructions
- Applications are accepted on an ongoing basis and can be submitted through the Madrigal Careers site.
Lead the vision, development, and lifecycle management of the global RIM platform, aligning with evolving regulatory, business, and user needs. Serve as the link between business and technology by 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.
Key Responsibilities
- RIM Strategy & Roadmap Ownership: Define and maintain the product vision and multi-year roadmap in close alignment with IT and Regulatory strategy; contribute to Regulatory Systems vision and strategy; assess 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 features/changes are compliant, scalable, and integrated; establish release schedule and coordinate releases with IT to ensure readiness of testing, training, communication, and documentation; drive user adoption and continuous improvement feedback loops.
- Compliance & Validation Ownership: Ensure 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 for proper documentation and traceability.
- Stakeholder Management & Change Management: 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; own communication channels to Key Users and End Users (including 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.
Qualifications
- 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/projects and aligning complex stakeholders.
- Strong communication planning, stakeholder engagement, and change adoption skills.
- Execution discipline, high accountability, structured thinking.
Preferred Qualifications
- 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.
- Ability to influence without authority across RA, IT, QA, and vendors.
Benefits
- Full-time employees are eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision, life/disability insurance, and 401(k) offerings (traditional, Roth, and employer match, in accordance with applicable plans). Additional voluntary benefits may include supplemental life insurance and legal services; mental health benefits via an Employee Assistance Program.
Application Instructions
- Applications are accepted on an ongoing basis and can be submitted through the Madrigal Careers site.