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

Regulatory Scientist

Location: 

Anderlecht, Brussels, Belgium

Job Function:  Regulatory Affairs
Job ID:  66755

Regulatory Scientist
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: Regulatory Scientist.


What We Offer

An opportunity to:

  • Prepare and deliver regulatory operational plans for assigned projects/products within a specific region. 
  • Provide strategic and operational regulatory input and guidance in cross-functional teams. 
  • Manage regulatory submissions to agreed project targets. 
  • Work flexibly within the EU and across regions to provide broad operational support to ensure the delivery of product team and business objectives.


About the Role

Your responsibility will be to:

  • Support the EU Regulatory Science Lead (RSL) and the Global Regulatory Leader (GRL) for the delivery of timely approvals and up-to-date Product Information/labelling, in line with the needs identified by internal and external stakeholders, and in compliance with relevant UCB procedures and regional/local country regulations.
  • Lead the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle.
  • Ensure that appropriate, up-to-date records are maintained in the Regulatory Information Management systems for compliance
  • Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice and operational support
  • Identify potential regulatory risks to the operational plan, and propose options to mitigate risks.
  • Provide regulatory expertise on regulatory submissions and health authority response documents
  • Maintain awareness of competitors’ activities and share potential impact these activities may have on the product development program
  • Assist in development of regulatory standards and SOPs

 

About You

You should have:

  • Relevant academic Master’s degree 
  • At least 3-5 years hands-on experience in Regulatory Affairs, with knowledge of assigned regional regulatory procedures and legislation, and focus on life cycle management for complex therapeutics
  • Organizational Skills 
  • Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
  • Build effective partnerships – identifies opportunities and takes actions to build effective relationships within team and with other areas
  • Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
  • Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person.  Works effectively in ambiguous situations.
  • Results focused – ability to overcome obstacles and achieve key outcomes
  • Analytical – logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
  • Integrity – overriding commitment to integrity and high standards in self and other

 

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 € 4.9 billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
 

 

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