Regulatory Submission Manager (Belgium)

We are looking for a Regulatory Submission Manager to join us in our Business Submissions & Operations (Regulatory Operations) team, based in any of our Brussels (Belgium), Monheim (Germany) or Slough (UK) offices.

About The Role

The Dossier Manager plays a critical role in streamlining and facilitating efficient end to end submission process. He/she will work in partnership with the Business Submissions & Operations team, for the definition and management of global and regional publishing strategies for their assigned product (s) to meet all regulatory submission requirements, ensuring that Application structure, metadata and submission archives are compliant and consistent throughout the end-to-end submissions process, enabling effective re-use between submissions.

Who You’ll Work With

You will report into the Regional Dossier Management Lead

What You’ll Do

• Perform publishing and/or compilation activities for reports and for submissions to Regulatory Authorities using existing technology and in accordance with internal business processes and regulatory requirements to meet designated timelines.
• Produce the electronic output for submissions and conduct technical validation to ensure compliance with authority requirements. Produce other outputs where required.
• Manage all technical aspects for assigned submissions
• Coordinate and track delivery of submissions to affiliates/partners or regulatory authorities and confirm receipt of the submissions upon request.
• Lead or participate as a SME in the development of global processes and standards for regulatory submissions and technology projects to ensure that they meet evolving agency requirements and corporate quality standards as assigned. This may include business process documentation, system testing, validation, assisting with pilot submissions.
• Ensure all dossiers comply with international and local regulatory guidelines, such as the Common Technical Document (CTD) or eCTD format.

Interested? For this position you’ll need the following education, experience and skills:

• Bachelor’s degree
• Ability to bring complex assignments through to completion
• Experience in preparation of documents for regulatory submissions to meet authority requirements and company standards, including extensive knowledge of Microsoft Word and Adobe Acrobat functionality.
• Extensive knowledge of regional regulatory agency requirements for electronic submissions format and delivery including detailed knowledge of eCTD specifications and validation requirements. Some direct experience with regulatory agencies.
• Extensive knowledge of standard industry submission technologies (document management and publishing tools) and best practices related to submission preparation, archiving, and tracking.

If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB .

RANDATUCB

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 equitable 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 and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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.