Associate Director, Regulatory Content & Digital Ops

Merck; Rahway (NJ); Hybrid; USD 180,000 - 230,000; Full time

Job summary

Merck in Rahway, NJ seeks an Associate Director of Regulatory Operations Content Management to partner with Regulatory Affairs, CMC, Quality, IT, and global stakeholders. The role focuses on governance, AI-driven content, and scalable regulatory execution across modalities.

The ideal candidate combines CMC operational expertise with strategic business acumen, strong communication, and change-management capabilities to modernize regulatory platforms and readiness for evolving health authority

Qualifications

• Bachelor’s degree 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.
• 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 objectives.
• Define governance models, operating standards, and scalable processes.
• Lead cross-functional initiatives to accelerate submissions and reduce complexity.
• Identify opportunities to leverage AI, structured content, and digital tech for regulatory ops.
• Support strategic planning, business cases, and executive communication.
• Serve as SME for enterprise regulatory content capabilities and governance.
• Champion structured content management and AI-enabled submission models.
• Support implementation of Regulatory Information Management (RIM) and content platforms.
• Mentor Regulatory CMC staff and foster innovation and accountability.

Skills

Regulatory content management

Regulatory operations

Digital transformation

Cross-functional collaboration

Stakeholder management

Effective communication

Education

Bachelor’s degree (required)

Advanced degree preferred

Tools

Veeva Vault (RIM/QMS)

Lorenz docuBridge

Appian

Power BI

Job description

Merck in Rahway, NJ seeks an Associate Director of Regulatory Operations Content Management to partner with Regulatory Affairs, CMC, Quality, IT, and global stakeholders. The role focuses on governance, AI-driven content, and scalable regulatory execution across modalities.

The ideal candidate combines CMC operational expertise with strategic business acumen, strong communication, and change-management capabilities to modernize regulatory platforms and readiness for evolving health authority