Director, Regulatory Affairs-CMC

Job Description Position Summary 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.

Key Responsibilities: Content Management Leadership ·       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.

Operational Excellence and Governance ·       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. Digital Enablement ·       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. CMC Regulatory Operations Partnership ·       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. Leadership and Stakeholder Engagement ·       Influence and collaborate effectively across global teams, senior stakeholders, and cross-functional par