Associate Director, Strategic Regulatory Content & Operations

Merck; Rahway (NJ); On-site; USD 150,000 - 210,000; Full time

Job summary

Merck is seeking an Associate Director of Regulatory Operations Content Management to partner across Regulatory Operations and CMC, driving strategic initiatives and scalable regulatory execution in a dynamic, AI-enabled environment.

The role focuses on governance, structured content, and collaboration with global stakeholders to optimize submissions, content reuse, and digital transformations across multiple therapeutic modalities.

Qualifications

• Experience in Regulatory Operations supporting submissions, content lifecycle, and registration management.
• Strong understanding of CMC regulatory activities and global requirements.
• Ability to lead cross-functional teams and influence change in a digital/AI-enabled environment.

Responsibilities

• Support long-term Regulatory Operations strategy aligned with Regulatory Affairs and CMC objectives.
• Define governance models, operating standards, and processes for scalable regulatory execution.
• Contribute to initiatives leveraging automation, AI, and structured content for inspection readiness.
• Partner with Regulatory authors and SMEs to optimize authoring processes and reduce content duplication.
• Support RIM, Document Management Systems, and regulatory content platforms optimization.

Skills

Regulatory Ops

Content Management

CMC knowledge

Stakeholder leadership

AI enablement

Job description

Merck is seeking an Associate Director of Regulatory Operations Content Management to partner across Regulatory Operations and CMC, driving strategic initiatives and scalable regulatory execution in a dynamic, AI-enabled environment.

The role focuses on governance, structured content, and collaboration with global stakeholders to optimize submissions, content reuse, and digital transformations across multiple therapeutic modalities.