Director, CMC Regulatory Processes and Systems

• Map processes, systems, and tools used for regulatory CMC activities from early development through lifecycle management
• Deliver and implement simplified, robust end-to-end processes with stakeholders and document them through guides or procedures
• Collaborate with Regulatory Operations to enhance Veeva RIM/eDMS capabilities and streamline regulatory CMC processes
• Develop reporting mechanisms covering compliance status, risks, and system performance
• Use data analytics and reporting tools to track compliance metrics and generate actionable insights
• Establish processes, systems, and metrics to identify source documents, monitor deliverables, track dossier readiness, submissions, approvals, launches, and implementation changes
• Lead sustainable improvement systems and tools and promote a culture of continuous improvement
• Establish tools for clinical trial applications, marketing applications, and post-approval activities
• Maintain the regulatory CMC strategic plan across assets and identify synergies or conflicts
• Create visibility and reporting on team activities
• Build and maintain a platform capturing intercontinental CMC submission requirements and communicate them to stakeholders
• Coordinate Regulatory CMC Intelligence activities, including regulatory comment consolidation and coordination
• Establish working groups to capture future regulatory requirements in ways of working
• Ensure systems, tools, and interfaces support effective collaboration with stakeholders
• Support budget and resource planning
• Establish and maintain the team training matrix
• Lead or participate in projects improving efficiency, effectiveness, compliance, and costs
• Create, share, and maintain standard dossier section templates
• Coach and mentor team members on continuous improvement skills and projects
• Extract and digitalize data practices for business use
• Monitor industry trends and regulatory changes and adjust processes and systems proactively

• Advanced degree in Life Sciences, Information Technology, Regulatory Affairs, or related field
• Minimum 10 years' experience in pharmaceutical CMC environment
• Experience in regulatory processes, regulatory submissions, and approvals
• Experience in strategic planning, execution, and reporting of regulatory data
• Experience transforming organizations and ways of working
• Experience overseeing IT business systems and data management
• Strong business acumen
• Experience with eDMS systems for regulated environments
• Strong ownership and cross-boundary working mindset
• Strong analytical and problem-solving capability
• Strong ability to lobby, influence, and negotiate
• Strong ability to map and define end-to-end processes
• Continuous improvement mindset
• Strong written, verbal, and interpersonal communication skills
• Ability to deal with people at all levels across all functions in a global environment
• Self-motivated, curious, willing to challenge, and able to support cross-functional teams
• Strong leadership and team management skills, with ability to inspire and motivate diverse teams and drive cultural change
• Fluent in English
• Strong understanding of global regulatory requirements and compliance standards
• Proficient in advanced analytics, IT business systems, and data management
• Strong interest in Artificial Intelligence and new technology
• Strong automatization and digitalization technical skills
• Ability to use standard project management tools
• Proficient in Veeva Vault RIM and other regulatory systems
• Proficient in Microsoft Office, Teams, SharePoint, MS Project, Power BI, and Visio

Demonstrates expertise in regulatory CMC processes, including strategic planning, compliance reporting, and data management. Proficient in utilizing advanced analytics and regulatory systems to drive continuous improvement and effective collaboration across global teams.

• Regulatory CMC Experience
• Veeva Vault RIM Proficiency
• Data Management Expertise
• Continuous Improvement Mindset
• Strong Leadership Skills

• Regulatory Processes
• Regulatory Submissions
• Strategic Planning
• Data Analytics
• Process Mapping
• Compliance Reporting
• Automation Skills
• Digitalization Skills
• IT Business Systems
• Advanced Analytics

• Strong Communication Skills
• Analytical Problem-Solving
• Influencing and Negotiation
• Cross-Functional Collaboration
• Team Management

• Pharmaceutical CMC
• Regulatory Compliance
• Global Regulatory Requirements
• Clinical Trial Applications
• Marketing Applications

• Veeva Vault RIM
• EDMS Systems
• Microsoft Office
• Power BI
• MS Project
• SharePoint
• Visio
• Teams