Associate Director, Regulatory Content & Digital Ops

Regulatory Jobs; Upper Gwynedd Township (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co. is seeking an Associate Director of Regulatory Operations Content Management to partner across Regulatory Affairs, CMC, Quality, IT, and Supply Chain, guiding digital transformation and scalable regulatory execution in a dynamic environment.

The role emphasizes governance, structured content, and AI-enabled tools, with leadership in content management, RIM, and document standards to ensure inspection readiness and efficient submissions across modalities.

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

• Support Regulatory Operations strategy aligned with enterprise objectives.
• Define governance models, operating standards, and processes for scalability and compliance.
• Contribute to cross-functional initiatives to improve regulatory effectiveness and submission execution.
• Identify opportunities to leverage automation, AI, structured content, and digital technologies.
• Support governance meetings, executive communications, and staff mentoring.

Skills

Content Management

AI Enablement

Regulatory Submissions

Regulatory Operations

Veeva Vault

RIM & QMS

Data Analytics

Stakeholder Management

Education

Bachelor’s degree

Advanced degree preferred

Tools

Veeva Vault (RIM)

Lorenz docuBridge

Appian

Power BI

Job description

Merck & Co. is seeking an Associate Director of Regulatory Operations Content Management to partner across Regulatory Affairs, CMC, Quality, IT, and Supply Chain, guiding digital transformation and scalable regulatory execution in a dynamic environment.

The role emphasizes governance, structured content, and AI-enabled tools, with leadership in content management, RIM, and document standards to ensure inspection readiness and efficient submissions across modalities.