Regulatory Submission Management Lead (BE)

Make your mark for patients

We are looking for a Regulatory Submission Management Lead to join us in our Global Regulatory Affairs team, based in either our Brussels (Belgium), Monheim (Germany) or Slough (UK)offices.

The Regional Regulatory Submission Management Lead is responsible for leading the regional Submission Management team and working as a Submission Manager lead for assigned assets to ensure the timely and accurate delivery of all submission related objectives regionally.

As a Regulatory Submission Management Lead you will have the following responsibilities:

• 
  Lead, train, mentor, coach, and develop members of the Regional Submissions Management team.
• Assess, manage, and allocate team resources to submissions, planning, process improvement initiatives and projects supporting company and Global Regulatory Affairs priorities.
• 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.
• Define and manage publishing and documentation strategies to meet all regional requirements and enable effective re-use between submissions.
• 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.
• Is responsible for the data and processes managed and/or supported by the Computerized System.
• Monitoring continued relevance and use of data; executing on the approved data lifecycle and recommending adaptions thereof as required

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

• 
  Bachelor’s degree
• Significant regulatory experience in the pharmaceutical industry or related industries with specific experience related to the management of Regulatory Submissions and Systems
• Several years in Regulatory Operations or similar function, including participation in implementation of new technologies as a subject matter expert
• Knowledge of regional regulatory agency requirements for submissions format and delivery
• Knowledge of standard industry submission technologies
• Strong leadership experience and track record of developing talent

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 for 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.

Learn more about sustainability at UCB and how it is integrated into our business approach.

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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.