Associate Director, Regulatory Affairs-CMC

Merck • North Wales, PA

8d • $142,400 - $224,100 • Hybrid

About The Position

The Associate Director of Regulatory Operations Content Management serves as a strategic business partner and subject matter expert supporting Regulatory Operations capabilities across submission planning, content management, and registration management. The role works with Regulatory Affairs, CMC, Quality, IT, Supply Chain, and global stakeholders to advance operational strategy, digital transformation, process optimization, and scalable regulatory execution across modalities and functions within Regulatory CMC.

The position supports enterprise Regulatory Operations strategy and governance, regulatory content and lifecycle management, structured authoring, content reuse, metadata, taxonomy, and document standards. It provides operational guidance for CMC submissions, lifecycle management, and global regulatory coordination, and supports product development, manufacturing changes, and post-approval activities.

The Associate Director contributes to digital modernization through implementation and adoption of regulatory platforms, AI-enabled tools, automation, and other technologies. Responsibilities also include release oversight, risk and impact assessment, readiness and continuity coordination, KPI strategy and analytics, and engagement with senior leaders and cross-functional teams. The role may mentor and coach Regulatory CMC staff and supports a culture of innovation, accountability, and continuous improvement.

Requirements

• 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.

Nice To Haves

• Advanced degree in Life Sciences, Regulatory Affairs, Information Systems, or a related field.
• System release management and impact assessment experience.
• Understanding of end-to-end business processes and the ability to evaluate upstream and downstream impacts of system changes.
• Experience supporting multiple release cycles simultaneously and managing competing priorities across differing timelines.
• Global submission lifecycle management experience, including coordination of submission content, workflows, and supporting systems.
• CMC Regulatory Operations experience, including submission planning, execution, and operational oversight.
• Knowledge of metadata management and data governance principles.
• Operational process design and workflow improvement experience.
• AI and digital enablement strategy experience.
• Experience with regulatory, content management, and structured data platforms.
• Hands-on experience with Veeva Vault (RIM and QMS), Lorenz docuBridge, Appian, and Microsoft Power BI.
• Strategic thinking and business acumen, executive presence and influence, cross-functional collaboration, change management, innovation and continuous improvement, and strong analytical and problem-solving capabilities.

Responsibilities

• Support long-term Regulatory Operations strategy aligned with enterprise Regulatory Affairs and CMC objectives.
• Help define governance models, operating standards, and business processes that promote consistency, compliance, scalability, and operational excellence.
• Contribute to cross-functional initiatives that improve regulatory effectiveness, accelerate submission execution, and reduce operational complexity.
• Identify opportunities to use automation, AI, structured content, and digital technologies to enhance Regulatory Operations.
• Support strategic planning, business case development, and executive-level communication.
• Support enterprise regulatory content strategy and governance for content lifecycle management, structured authoring, content reuse, metadata, taxonomy, and document standards.
• Improve document quality, consistency, reuse, and inspection readiness; partner with Regulatory authors and functional SMEs to optimize authoring processes and reduce redundant content creation.
• Champion structured and modular content strategies that enable AI, automation, and future regulatory submission models.
• Support implementation and optimization of Regulatory Information Management, Document Management Systems, and content management platforms.
• Serve as a strategic partner for CMC regulatory activities and submissions, including global submission standards, complex submission requirements, lifecycle management, and global regulatory coordination.
• Partner with CMC Regulatory Affairs and technical teams on product development, manufacturing changes, and post-approval activities.
• Contribute to global regulatory operations strategies, modernization efforts, roadmaps, governance, and cross-functional alignment.
• Help ensure operational processes support compliance, inspection readiness, and scalability.
• Support release activities by assessing technical changes, business impacts, and coordination needs; help manage release schedules, readiness, and continuity of execution.
• Identify release risks and gaps, and support communication, testing, and training.
• Lead or support governance meetings, strategic discussions, operational reviews, and executive presentations.
• Mentor and coach Regulatory CMC staff as needed and build partnerships across Regulatory Affairs, Quality, IT, Regulatory Operations, RIM, Supply Chain, and external partners.
• Support implementation and adoption of digital regulatory platforms, AI-enabled tools, automation capabilities, and operational technologies.
• Partner on software releases, platform enhancements, emerging digital capabilities, system requirements, and future-state operating models; evaluate emerging technologies for business applicability.
• Help establish digital governance, standards, and best practices, and support enterprise automation and process modernization initiatives.
• Support KPI strategy and performance measurement frameworks, drive data-informed decision-making through dashboards and insights, and contribute to KPI reporting standards and data quality governance.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Director