Strategic Leader — Regulatory Content & Operations (Hybrid)

Merck; North Wales (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Job summary

Merck in North Wales, PA seeks an Associate Director of Regulatory Operations Content Management to partner with senior leaders and SMEs, advancing regulatory content strategy across submissions and registration management in a digital/AI-enabled setting.

The role focuses on governance, standards, and scalable processes, driving modernization with AI, structured content, and RIM implementations. Collaboration across Regulatory CMC, IT, and external partners is essential.

Qualifications

• Bachelor's degree required; advanced degree preferred in Life Sciences, Regulatory Affairs, Information Systems, or related field.
• Deep expertise in regulatory content management and supporting digital transformation initiatives.
• Experience working across complex cross-functional organizations with strong communication skills.

Responsibilities

• Support long-term Regulatory Operations strategy aligned with enterprise objectives.
• Define governance models, operating standards, and scalable processes.
• Lead initiatives to improve regulatory effectiveness, automate content and AI-enabled capabilities.
• Partner with Regulatory authors and SMEs to optimize authoring and content reuse.
• Champion structured content management for AI, automation, and future submissions.
• Support implementation of Regulatory Information Management (RIM) and content platforms.

Skills

Content Management

Continuous Improvement

Data-Driven Decisions

Digital Governance

Digital Transformation

Document Control

eCTD

Regulatory CMC

Regulatory Compliance

Regulatory Operations

Regulatory Information Management

Regulatory Submissions

Regulatory Strategy

Stakeholder Management

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva Vault

Lorenz docuBridge

Appian

Power BI

Job description

Merck in North Wales, PA seeks an Associate Director of Regulatory Operations Content Management to partner with senior leaders and SMEs, advancing regulatory content strategy across submissions and registration management in a digital/AI-enabled setting.

The role focuses on governance, standards, and scalable processes, driving modernization with AI, structured content, and RIM implementations. Collaboration across Regulatory CMC, IT, and external partners is essential.