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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

People Leader

All Job Posting Locations:

Leiden, Netherlands

Job Description:

The Knowledge Management and Process Excellence Lead is a strategic role responsible for designing and driving best-in-class knowledge management practices, optimising operational regulatory submission processes, and ensuring continuous improvement across the Next Gen Submissions organization.

Main Duties & Responsibilities:
~50% of time:

• Develop and maintain a structured knowledge management framework including governance, taxonomy, and content lifecycle.
• Develop and maintain knowledge management technology platform.
• Lead the creation, organization, and dissemination of regulatory submissions process documentation, SOPs, work instructions, and best practices.
• Establish systems and tools for capturing institutional knowledge and regulatory submissions insights.
• Create and oversee training materials and learning resources for Next Gen Submissions onboarding and upskilling.
• Ensure version control and audit readiness for all process-related documentation.

 

 

Required Skills:

 

 

Preferred Skills: