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

Submissions and Planning Lead

Location: 

Anderlecht, Brussels, Belgium

Job Function:  Regulatory Affairs
Job ID:  65277

Global Regulatory Submission Management Lead

UCB – Inspired by patients. Driven by science.

Help us transform patients’ lives.

About UCB

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We look to transform patients’ lives by pushing the boundaries of what is possible. With us, our talent makes the most of who they are, unlocking innovation and setting new standards for patients.

 

Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.

 

To strengthen our Regulatory Affairs Group, we are looking to fill the position of: Global Regulatory Submission Management Lead.

 

What We Offer

An opportunity to:

  • Apply innovative solutions for optimization and impact in Regulatory Submissions.
  • Be a driver for progressive change and global delivery.
  • Ensure collaboration and work towards shared opportunities and targets.
  • Cultivate value that ultimately benefits our patients.

 

About the Role

You will be responsible for:

  • Leading the Submission Portfolio Management team to ensure the timely and accurate delivery of all submission related objectives globally.
  • Line management with a focus on talent development, high quality submission planning and delivery, as well as strong process and technical expertise.
  • Managing all aspects of the end to end Submission process such as planning, document management, publishing and dispatch. Strong communication and project management skills are required.
  • The development and implementation of the electronic systems and processes owned by Global Regulatory Affairs. This includes implementation within Global Regulatory Affairs, GRA delegates and with GRA stakeholders that use the systems and processes (e.g., Affiliates, Clinical, Non-Clinical, Safety, Pharmacovigilance, Technical Operations, Partners).
  • Ensuring the consistent use of submission standards, processes, and technologies globally couple with dissemination of information related to new Regulatory submission requirements and system implementations or upgrades supporting Regulatory submissions.

 

About You

You should have:

  • Prior Regulatory experience in pharmaceutical industry with management of regulatory submissions and systems. 
  • Previous regulatory operations experience or similar function; having implemented new technologies as a subject matter expert.
  • Knowledge of global regulatory agency requirements for submissions format and delivery related to project management or publishing.  
  • Solid knowledge of standard industry submission technologies.
  • English speaking ideally plus French but this is not essential.
  • Strong line management experience with a record of developing talent.

 

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7 500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news


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