Director, Regulatory Affairs-CMC

Merck•North Wales, PA

1d•$173,200 - $272,600•Hybrid

About The Position

The Director, CMC Operations Content Management and Digital Enablement will serve as a leader and subject matter expert responsible for advancing global CMC content management capabilities across the content lifecycle, including authoring, review, reuse, governance, metadata, taxonomy, and document standards. This role will partner closely with Regulatory Affairs, CMC, Quality, IT, and global business stakeholders to define and drive the content management strategy, operating model, and governance framework that support compliant, scalable, inspection-ready, and digitally enabled regulatory content processes. The ideal candidate combines deep regulatory content management expertise with strong leadership, process design, and change management capabilities. This individual will play a critical role in modernizing the CMC content environment, enabling structured and modular content approaches, and supporting digital tools and AI-enabled ways of working that improve efficiency, consistency, and business value.

Requirements

Bachelor’s degree required; advanced degree preferred in Life Sciences, Regulatory Affairs, Information Systems, or related field.
Extensive experience in content management, regulatory operations, or pharmaceutical operations, with strong emphasis on CMC content processes.
Demonstrated experience leading content management strategy, governance, or process improvement initiatives.
Experience with digital transformation, system implementation, or content platform optimization.
Strong communication, influence, and stakeholder management skills.
Demonstrated ability to work effectively across complex global and cross-functional environments.
Strong expertise in several of the following: Regulatory content management, Structured content and modular authoring, Metadata and taxonomy governance, Document lifecycle management, Global submission support processes, Operational process design and continuous improvement, Digital enablement strategies.
Experience with platforms such as: Veeva Vault, Lorenz docuBridge, Microsoft Power BI.
Strategic thinking and business acumen
Executive presence and influence
Content management and operational leadership
Change management and organizational leadership
Cross-functional collaboration
Innovation and continuous improvement mindset
Operational excellence
Talent development and mentorship
Strong analytical and problem-solving capability
Business Process Improvements
Business Process Improvements
Change Management
Compliance Remediation
Cross-Functional Project Management
Data Reporting
Document Control Systems
Employee Training Programs
Executive Leadership
Executive Presence
High Performance Team Building
Influencing Skills
Innovation
Negotiation
Organizational Capability
Organizational Leadership
People Leadership
Policy Implementation
Prioritization
Process Improvements
Regulatory Affairs Management
Regulatory Submissions
Stakeholder Management
Strategic Leadership
Strategic Thinking

Nice To Haves

Independent Judgment

Responsibilities

Define and lead the CMC content management strategy across the content lifecycle.
Establish governance, standards, and operating procedures for content creation, review, approval, reuse, maintenance, archiving, and retrieval.
Serve as the enterprise SME for content management processes supporting CMC regulatory activities.
Drive consistent application of document standards, metadata, taxonomy, and version control practices.
Ensure content management processes support compliance, inspection readiness, and global regulatory requirements.
Identify and implement opportunities to improve content quality, consistency, and reuse across the organization.
Champion structured authoring and modular content approaches to enable more efficient content operations and future digital capabilities.
Develop and maintain a scalable content management operating model aligned with business needs and regulatory expectations.
Partner with cross-functional stakeholders to define roles, responsibilities, workflows, and governance forums.
Lead process improvement initiatives that reduce duplication, improve efficiency, and strengthen control.
Establish and monitor performance metrics related to content quality, cycle time, reuse, compliance, and operational effectiveness.
Support audit and inspection readiness through strong content governance and data integrity practices.
Lead the implementation, optimization, and adoption of digital tools that support content management capabilities.
Partner with IT and business stakeholders to define business requirements, future-state workflows, and system enhancements.
Evaluate and advance opportunities to leverage automation, AI, structured content, and digital technologies to improve content operations.
Serve as a strategic business partner for content-related platform enhancements and digital capability roadmaps.
Support adoption of content management systems, document management tools, and related regulatory platforms.
Collaborate with CMC Regulatory Affairs and other stakeholders to ensure content management processes effectively support submission development and lifecycle activities.
Align content management practices with global regulatory requirements and CMC business priorities.
Provide operational guidance for content-related challenges, escalations, and continuous improvement opportunities.
Contribute to the modernization of CMC regulatory operations through improved content processes and digital readiness.
Influence and collaborate effectively across global teams, senior stakeholders, and cross-functional partners.
Lead governance discussions, working sessions, and executive-level presentations related to content management strategy and performance.
Build strong partnerships across Regulatory Affairs, Quality, IT, Supply Chain, and external vendors.
Mentor and develop team members and foster a culture of accountability, innovation, and continuous improvement.
Define KPI frameworks for content management performance and maturity.
Develop reporting standards and dashboards to support data-driven decision-making.
Monitor key measures such as content quality, reuse, compliance, cycle time, and digital adoption.
Present insights, trends, and recommendations to senior leadership to inform prioritization and improvement efforts.