Associate Director, Regulatory Content & AI Enablement

MSD; North Wales (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Holidays

Vacation

Sick Days

Job summary

Merck & Co., Inc. is seeking an Associate Director of Regulatory Operations Content Management to serve as a strategic SME, partnering with Regulatory Affairs, CMC, Quality, IT, and global stakeholders to drive digital transformation and scalable regulatory execution.

The role focuses on governance, structured content, and RIM/QMS platforms, with leadership across cross-functional teams and a path to advanced regulatory capabilities that align with health authority expectations.

Qualifications

• Bachelor’s degree required; advanced degree preferred in Life Sciences, Regulatory Affairs, Information Systems, or related field.
• 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

• Define governance models, operating standards, and processes for scalable regulatory execution.
• Support enterprise regulatory content capabilities and structured content management.
• Partner with Regulatory authors and SMEs to optimize authoring and reduce redundancy.
• Lead or support governance meetings, strategic discussions, and executive presentations.
• Support digital platforms, AI-enabled tools, and regulatory information management systems.

Skills

Content Management

Data-Driven Decision Making

Digital Governance

Digital Transformation

Regulatory CMC

Regulatory Compliance

Regulatory Information Management

Regulatory Operations

Regulatory Submissions

Stakeholder Partnerships

Regulatory Strategy

Document Control

eCTD

Veeva Vault

Appian

Education

Bachelor’s degree

Advanced degree preferred

Tools

Veeva Vault

Lorenz docuBridge

Appian

Power BI

Job description

Merck & Co., Inc. is seeking an Associate Director of Regulatory Operations Content Management to serve as a strategic SME, partnering with Regulatory Affairs, CMC, Quality, IT, and global stakeholders to drive digital transformation and scalable regulatory execution.

The role focuses on governance, structured content, and RIM/QMS platforms, with leadership across cross-functional teams and a path to advanced regulatory capabilities that align with health authority expectations.