Associate Director, Regulatory Operations & Content

MSD; Rahway (NJ); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Hybrid work model

Annual bonus

Long-term incentive

Job summary

Merck & Co., Inc. in North Wales, PA, USA, seeks an Associate Director to advance Regulatory Operations content management and strategic initiatives across CMC and global submissions.

The role partners with Regulatory Affairs, IT, Quality, and Supply Chain to drive modernization and scalable regulatory execution. The ideal candidate combines CMC regulatory expertise with business acumen, strong communication, and the ability to influence change.

Qualifications

• Bachelor’s degree required.
• 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 long-term Regulatory Operations strategy aligned with enterprise objectives.
• Define governance models, operating standards, and business processes for consistency and scalability.
• 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 for content lifecycle management, structured authoring, metadata, taxonomy, and document standards.
• Help implement and optimize Regulatory Information Management (RIM), Document Management Systems, and content platforms.

Skills

Content Management

Continuous Improvement Techniques

Data-Driven Decision Making

Digital Governance

Digital Transformation Initiatives

Document Control Systems

Electronic Common Technical Document (

Education

Bachelor’s degree; advanced degree preferred in Life Sciences, Regulatory Affairs, Information Systems, or related field

Tools

Veeva Vault (RIM/QMS)

Lorenz docuBridge

Appian

Microsoft Power BI

Job description

Merck & Co., Inc. in North Wales, PA, USA, seeks an Associate Director to advance Regulatory Operations content management and strategic initiatives across CMC and global submissions.

The role partners with Regulatory Affairs, IT, Quality, and Supply Chain to drive modernization and scalable regulatory execution. The ideal candidate combines CMC regulatory expertise with business acumen, strong communication, and the ability to influence change.