CMC Documentation Lead

il y a 2 semaines

Brainel'Alleud, Belgique UCB Temps plein

Make your mark for patientsWe are looking for a Technical Leadership Documentation Lead who is organized and detail-oriented to join our Technical Lead (TL) Community & Portfolio Excellence team based out of our campus in Braine L’Alleud, Belgium.About the roleYou will coordinate activities for preparing CMC regulatory dossiers for clinical studies and product registrations. This includes CMC sections for Clinical Trial Applications, Marketing Authorisations, and post-approval CMC changes. You will ensure all supporting documents are identified and accurate, represent Technical Leadership in knowledge management, and serve as the central point for regulatory consultation and implementation.Who you’ll work withYou will collaborate with project leaders, regulatory CMC representatives, technical teams, and the CMC Dev Sciences organization.What you’ll doCoordinate and prepare technical documentation for regulatory dossiers.Plan document delivery timelines with project leaders.Facilitate communication between regulatory and technical teams.Organize and lead meetings to ensure timely, accurate documentation.Guide preparation of high-quality, compliant regulatory documents.Identify gaps and technical needs for regulatory compliance.Participate in project meetings and manage dossier preparation activities.Maintain and update internal guidance and documentation standards.Support knowledge management and represent Technical Leadership in related teams.Serve as entry point for new regulations and collaborate on regulatory guidelines.Interested? For this role we’re looking for the following education, experience and skillsBachelor’s, Master’s, or PhD degree required.General understanding of chemical, biological, pharmaceutical, and technical projects.Awareness of regulatory requirements for CMC dossier preparation (Europe, US, China, Japan).Understanding of quality aspects for projects under development (GxP rules).Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you 

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