Regulatory Operations Lead, Content & Digital Innovation

MSD; Pennsylvania; Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Hybrid work environment

Job summary

MSD is seeking an Associate Director for Regulatory Operations Content Management to drive strategic regulatory capabilities in a hybrid role across North Wales, PA and Rahway, NJ. You will shape governance, enable AI-enabled content strategies, and partner with IT, Quality, and Regulatory teams to optimize submissions and lifecycle management.

The role emphasizes CMC operations, global submission coordination, and the modernization of regulatory information management with a focus on scalable

Qualifications

• Experience in Regulatory Operations, Regulatory Affairs, or pharmaceutical operations.
• Deep expertise in regulatory content management.
• Experience supporting digital transformation initiatives and regulatory system implementations.
• Demonstrated ability to work across complex cross-functional organizations and multiple modalities.
• Strong communication, presentation, and stakeholder management skills.

Responsibilities

• Support long-term Regulatory Operations strategy aligned with enterprise Regulatory Affairs and CMC objectives.
• Define governance models, operating standards, and business processes for consistency and scalability.
• Contribute to cross-functional initiatives to improve regulatory effectiveness and submission execution.
• Identify opportunities to leverage automation, AI, structured content, and digital technologies.
• Partner with Regulatory authors and SMEs to optimize authoring processes and content reuse.
• Collaborate on governance for content lifecycle management and metadata standards.
• Support implementation and optimization of RIM, DMS, and content platforms.
• Lead or support governance meetings, executive presentations, and cross-functional reviews.

Skills

Content Management

Continuous Improvement Techniques

Data-Driven Decision Making

Digital Governance

Digital Transformation Initiatives

Document Control Systems

eCTD

Regulatory CMC

Regulatory Compliance

Regulatory Experience

Regulatory Information Management

Regulatory Operations

Regulatory Strategy Development

Regulatory Submissions

Stakeholder Partnerships

Education

Bachelor’s degree

Advanced degree preferred

Tools

Veeva Vault

Lorenz docuBridge

Appian

Microsoft Power BI

Job description

MSD is seeking an Associate Director for Regulatory Operations Content Management to drive strategic regulatory capabilities in a hybrid role across North Wales, PA and Rahway, NJ. You will shape governance, enable AI-enabled content strategies, and partner with IT, Quality, and Regulatory teams to optimize submissions and lifecycle management.

The role emphasizes CMC operations, global submission coordination, and the modernization of regulatory information management with a focus on scalable