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Global Regulatory Devices Scientist

Location: 

Anderlecht, Brussels, Belgium

Job Function:  Regulatory Affairs
Job ID:  68278

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Regulatory Scientist – Devices (focus on Combination Products)

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 Global Regulatory Affairs CMC & Devices team, we are looking to fill the position of: Global Regulatory Scientist Devices.  

 

 

What We Offer

An opportunity to:

  • Take responsibility for the regulatory Device strategy for Combination products throughout the Life-Cycle (CTA, MAA/BLA and post approval variations).
  • Define strategy, planning and preparation of device specific submission documentation for assigned projects and contribute to the preparation of global submission documentation to deliver timely approvals to meet business needs.
  • Leading and/or provide regulatory device input to all Health Authorities (HA) interactions on device matters in assigned regions as agreed with the GRA-CMC & Devices Leadership Team.

 

About the Role

You will be responsible for:

  • Developing and implementing the regulatory CMC Device strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.
  • Taking “Hands-on” accountability by managing CMC device projects yourself and writing global CMC device documentation for submissions (Module 3 and device technical files) in line with agreed global regulatory strategy, and within agreed timelines. Writing of submission documents based on technical source reports.
  • Ensuring effective communication of regulatory device strategy, risks, and overall plan for assigned projects to the Regulatory Affairs Teams, Supply &Technology Solution Teams and Patient Value teams as agreed with the Global Regulatory CMC Lead.  

 

About You

You should have:

  • Motivation and enthusiasm as a team player who works well in global teams but can also work independently. Someone that likes working in a matrix environment across different cultures and someone that establishes strong and effective relationships with global regulatory teams.
  • “Can do” attitude with pragmatic solutions while working within a regulated environment
  • Proven track record of successful delivering regulatory device submission documents.
  • Willing to learn new topics and broadening your horizon
  • Educated preferably to a master’s level, in a relevant life science or technical related discipline
  • Several years relevant experience in the pharmaceutical industry or a regulatory authority CMC/devices review capacity, with at least 2 years of experience in devices and preferably 3 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
  • Knowledge of device requirements (focus on combination products), clinical trial submission, product registration/variations, and license maintenance. Global regulatory experience is a plus.

 

 

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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