Associate Director, Regulatory Affairs-CMC

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

Role Overview

The Associate Director of Regulatory Operations Content Management will serve as a strategic business partner and subject matter expert (SME) supporting the advancement of Regulatory Operations capabilities across submission planning, content management, and registration management within a dynamic digital and AI-enabled pharmaceutical environment.

Job Description

The Associate Director of Regulatory Operations Content Management will serve as a strategic business partner and subject matter expert (SME) supporting the advancement of Regulatory Operations capabilities across submission planning, content management, and registration management within a dynamic digital and AI-enabled pharmaceutical environment. This role will partner closely with Regulatory Affairs, CMC, Quality, IT, Supply Chain, and global business stakeholders to support operational strategy, digital transformation, process optimization, and scalable regulatory execution across multiple therapeutic modalities and organizational functions within Reg CMC. The ideal candidate combines strong CMC operational expertise with sound business judgment, effective communication skills, and the ability to influence change. This individual will help support digital initiatives, contribute to modernization efforts, and enable future-state regulatory capabilities that improve scalability, efficiency, and readiness for evolving health authority expectations and AI-enabled ways of working.

Regulatory Operations Support

• Support long-term Regulatory Operations strategy aligned with enterprise Regulatory Affairs and CMC objectives.
• Help define governance models, operating standards, and business processes that promote consistency, compliance, scalability, and operational excellence.
• Contribute to cross-functional initiatives that improve regulatory effectiveness, accelerate submission execution, and reduce operational complexity.
• 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.

Content Management

Serve as the subject matter expert supporting enterprise regulatory content capabilities by:

• Supporting the enterprise content management strategy across Regulatory CMC.
• Contributing to governance for content lifecycle management, structured authoring, content reuse, metadata, taxonomy, and document standards.
• Supporting initiatives that improve document quality, consistency, reuse, and inspection readiness.
• Partnering with Regulatory authors and functional SMEs to optimize authoring processes and reduce redundant content creation.
• Championing structured content management and modular content strategies that enable AI, automation, and future regulatory submission models.
• Supporting implementation and optimization of Regulatory Information Management (RIM), Document Management Systems, and content management platforms.

CMC Regulatory Operations Expertise

• Serve as a strategic partner supporting CMC regulatory activities and submissions.
• Collaborate with Regulatory Operations to support standards that align with global requirements for Health Authority submissions.
• Provide operational guidance for complex CMC submission requirements, lifecycle management, and global regulatory coordination.
• Partner with CMC Regulatory Affairs and technical teams to support product development, manufacturing changes, and post-approval activities.

Strategic And Operational Support

• Support global regulatory operations strategies and modernization efforts aligned to business priorities.
• Contribute to roadmaps, governance, and cross-functional alignment across business functions.
• Help ensure operational processes support compliance, inspection readiness, and scalability.