Regulatory Platform Strategy Leader

MSD; North Wales (Montgomery County); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Healthcare, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co., Inc. is seeking a senior Regulatory operations leader to govern the end-to-end RIIM subunit, driving harmonized digital strategy and managing a cross-functional workforce of employees, contractors, and vendors.

The role requires extensive experience in regulatory operations, Veeva RIM, and strategic execution, with responsibility for budgets, vendor contracts, and talent planning. A hybrid work model and international collaboration are expected.

Qualifications

• 10+ years in a Regulatory operations role.
• 5+ years leading teams and a hybrid organization of employees, contractors, and vendors.
• Significant experience in Veeva RIM operations.
• Experience with innovation strategy, implementation, and operations of digital solutions in a regulated environment.
• Expertise in regulatory capabilities, operations, and business processes.
• Strong experience collaborating with IT, Finance, HR, and vendors.
• Ability to drive CAPAs/NCIRs resolutions, partner audits and Health Authority inspections.
• Ability to represent the organization at internal and external forums on RIM topics.
• Executive presence and ability to engage stakeholders.
• Demonstrated ability to recruit, train, and develop staff in a matrix international environment.

Responsibilities

• Act as a horizontal platform integrator across RIIM systems.
• Drive platform lifecycle management, including releases, enhancements, and cross-system coordination.
• Maintain governance frameworks for consistency, compliance, and performance.
• Shape platform roadmap with BSOs, stakeholders, IT, and vendors.
• Ensure platforms are scalable, usable, and compliant.
• Define and monitor KPIs for system usage, adoption, and value delivery.
• Lead a centralized capability for systems adoption, user analytics, and insights generation.
• Oversee Regulatory BCPs, readiness, scenario planning, and incident coordination.
• Provide BSO for cross-cutting RIIM tools (e.g., IPV Dashboard, Veeva AI).
• Translate GRACS digital strategy into execution and communications.

Skills

Regulatory operations

Veeva RIM

Leadership

Cross-functional collaboration

Strategic planning

Digital strategy

Stakeholder management

Regulatory compliance

Analytics & KPIs

Change management

Education

MS or equivalent in related field

BA/BS in Science/Business/IT

Tools

Veeva

BI/Analytics tools

Regulatory systems governance

Job description

Merck & Co., Inc. is seeking a senior Regulatory operations leader to govern the end-to-end RIIM subunit, driving harmonized digital strategy and managing a cross-functional workforce of employees, contractors, and vendors.

The role requires extensive experience in regulatory operations, Veeva RIM, and strategic execution, with responsibility for budgets, vendor contracts, and talent planning. A hybrid work model and international collaboration are expected.