Make your mark for patients

We 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 role
You 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 with
You will collaborate with project leaders, regulatory CMC representatives, technical teams, and the CMC Dev Sciences organization.

 

What you’ll do

Coordinate 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 skills

Bachelor’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! 

About us 
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science. 

Why work with us? 
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. 

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
 
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.