Associate Director, Regulatory Content & Transformation

Merck & Co.; Rahway (NJ); Hybrid; USD 142,000 - 224,000; Full time

Job summary

Merck & Co. is seeking an Associate Director of Regulatory Operations Content Management to partner with Regulatory Affairs, CMC, Quality, IT, and Supply Chain.

You will support strategy, governance, and scalable regulatory execution across modalities within Reg CMC, focusing on content management and modernization. The role emphasizes governance, structured content, AI-enabled tools, and platform optimization, including RIM and QMS systems, to drive efficiency, inspection readiness, and

Qualifications

• Bachelor's degree in life sciences or regulatory affairs.
• Experience in Regulatory Operations 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.
• Strong communication, presentation, and stakeholder management skills.

Responsibilities

• Support long-term Regulatory Operations strategy aligned with enterprise Regulatory Affairs and CMC objectives.
• Help define governance models, operating standards, and business processes for consistency, scalability and compliance.
• Contribute to cross-functional initiatives that improve regulatory effectiveness and submission execution.
• Identify opportunities to leverage automation, AI, structured content, and digital technologies to enhance Regulatory Operations.
• Support strategic planning, business case development, and executive-level communication as needed.
• Mentor and coach Regulatory CMC staff while fostering innovation and accountability.

Skills

Regulatory Operations

Content Management

Digital Transformation

Stakeholder Management

Leadership

Communication

AI & Automation

Cross-functional Collaboration

Education

Bachelor's degree

Advanced degree in Life Sciences/Regulatory Affairs/Information Systems

Tools

Veeva Vault

Lorenz docuBridge

Appian

Power BI

Job description

Merck & Co. is seeking an Associate Director of Regulatory Operations Content Management to partner with Regulatory Affairs, CMC, Quality, IT, and Supply Chain.

You will support strategy, governance, and scalable regulatory execution across modalities within Reg CMC, focusing on content management and modernization. The role emphasizes governance, structured content, AI-enabled tools, and platform optimization, including RIM and QMS systems, to drive efficiency, inspection readiness, and