Associate Director, Regulatory Content & Ops

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Hybrid work arrangement

Job summary

Merck & Co. is seeking an Associate Director of Regulatory Operations Content Management to act as a strategic SME supporting submissions planning, content management, and registration management in a digital, AI-enabled pharmaceutical setting.

You will partner with Regulatory Affairs, CMC, Quality, IT, and Supply Chain to drive modernization, governance, and scalable regulatory execution across modalities and functions.

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

• Partner with regulatory functions to support strategy and execution.
• Define governance models, operating standards, and processes for consistency and scalability.
• Support automation, AI, and digital technologies in regulatory operations.
• Lead or participate in governance meetings and executive presentations.
• Mentor Regulatory CMC staff and drive continuous improvement.

Skills

Regulatory Operations

Regulatory Affairs

Pharmaceutical operations

Cross-functional collaboration

Communication skills

Education

Bachelor's degree

Advanced degree preferred

Tools

Veeva Vault (RIM and QMS)

Lorenz docuBridge

Appian

Microsoft Power BI

Job description

Merck & Co. is seeking an Associate Director of Regulatory Operations Content Management to act as a strategic SME supporting submissions planning, content management, and registration management in a digital, AI-enabled pharmaceutical setting.

You will partner with Regulatory Affairs, CMC, Quality, IT, and Supply Chain to drive modernization, governance, and scalable regulatory execution across modalities and functions.