Loading...
Share this Job
Apply now »

 

Let's push the boundaries together and make the most of your talents!

Regulatory Affairs Swiss liaison

Location: 

Anderlecht, Brussels, Belgium

Job Function:  Regulatory Affairs
Job ID:  69207

Regulatory Affairs, Swiss Liaison

 

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

As the Swiss Liaison your role will encompass two aspects;

  • The first is to be responsible for Swiss-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 SwissMedic and UCB 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, clinical trials and product registration processes within Switzerland.
  • 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 SwissMedic.

 

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 »