Director, Regulatory Affairs – CMC

• 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 subject matter expert 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
• Champion structured authoring and modular content approaches
• Develop and maintain a scalable content management operating model
• Define roles, responsibilities, workflows, and governance forums with cross-functional stakeholders
• Lead process improvement initiatives and establish performance metrics
• Support audit and inspection readiness through content governance and data integrity practices
• Lead implementation, optimization, and adoption of digital content management tools
• Define business requirements, future-state workflows, and system enhancements with IT and business stakeholders
• Evaluate automation, AI, structured content, and digital technologies
• Support content management systems, document management tools, and regulatory platforms
• Collaborate with CMC Regulatory Affairs on submission development and lifecycle activities
• Provide operational guidance for content-related challenges and escalations
• Lead governance discussions, working sessions, and executive-level presentations
• Build partnerships across Regulatory Affairs, Quality, IT, Supply Chain, and external vendors
• Mentor and develop team members
• Define KPI frameworks, reporting standards, and dashboards
• Monitor content quality, reuse, compliance, cycle time, and digital adoption
• Present insights, trends, and recommendations to senior leadership

• Bachelor’s degree required in Life Sciences, Regulatory Affairs, Information Systems, or related field; advanced degree preferred
• 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
• Ability to work effectively across complex global and cross-functional environments
• Strong expertise in 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, and digital enablement strategies
• Experience with Veeva Vault, Lorenz docu Bridge, and Microsoft Power BI
• Strategic thinking and business acumen
• Executive presence and influence
• 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
• No visa sponsorship
• US and Puerto Rico residents only

Demonstrates expertise in content management strategy, governance, and regulatory compliance within the CMC domain, while effectively leading cross-functional collaboration and process improvement initiatives. Proficient in digital content management tools and methodologies to enhance content quality and operational efficiency.

• Content Management Strategy
• Regulatory Content Management
• Digital Transformation
• Veeva Vault
• Process Improvement Initiatives

• Content Lifecycle Management
• Document Lifecycle Management
• Metadata Governance
• Taxonomy Governance
• Structured Authoring
• Modular Content Approaches
• Operational Process Design
• Continuous Improvement
• KPI Frameworks
• Digital Enablement Strategies

• Strong Communication
• Stakeholder Management
• Change Management
• Cross-Functional Collaboration
• Talent Development

• Life Sciences
• Regulatory Affairs
• Pharmaceutical Operations
• Inspection Readiness
• Global Regulatory Requirements

• Veeva Vault
• Lorenz docu Bridge
• Microsoft Power BI
• Content Management Systems
• Document Management Tools