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Regulatory Affairs UK Liaison

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Regulatory Affairs
Job ID:  69053

Regulatory Affairs, UK Liaison

 

To strengthen our Regulatory Affairs department based in our UK Head office, in Slough, we are looking for a talented individual to fill the position of: Regulatory Affairs, UK Liaison.
 

As the UK Liaison your role will be have two aspects;

  • The first is to be responsible for UK-specific regulatory oversight on marketed and investigational biologic and NCE products at UCB. 
  • The second aspect is to prepare and deliver regulatory operational plans for assigned projects/products within the broader EU region.

 

You will contribute by:

  • Advising the development teams on local strategy and procedures.
  • Serving as the primary regulatory liaison between the MHRA and UCB and will provide leadership and oversight of the transition of the MHRA through BREXIT to help ensure any impact on business continuity is minimized.
  • Liaising with a contract organisation that provides the local affiliate regulatory resource to ensure alignment.
  • Providing strategic and operational regulatory input and guidance in cross-functional teams and manage quality regulatory submissions to agreed project targets.
  • Working flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.

 

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

  • Several years of Regulatory Affairs experience within biotech/pharma industry with a preference for a successful track record in biologic and pharmaceutical product submissions.
  • In-depth knowledge of the drug development, CTA, product registration processes and the MHRA.
  • Demonstrated experience preparing chemistry, preclinical and clinical CTA submissions.
  • Proven ability in project leadership and representing the company in formal meetings including presentations to and negotiations ideally with the MHRA.

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

Apply now »