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Global Regulatory CMC Scientist - Small Molecule

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Regulatory Affairs
Job ID:  68107

Regulatory CMC Scientist Small Molecule

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 CMC Scientist – Small Molecule.

 

 

What We Offer

An opportunity to:

  • Take responsibility for the regulatory CMC support of biological and/or chemical entities throughout the Life-Cycle (early to late development, Clinical Trial Application writing and CTA support, writing of MAA/BLAs/NDAs and post approval variations)
  • Define strategy, planning and preparation of (regional) specific CMC 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 CMC input to all Health Authorities (HA) interactions on CMC matters in assigned regions as delegated by Global Regulatory CMC Lead and agreed with the GRA-CMC & Devices Leadership Team

 

About the Role

You will be responsible for:

  • Developing and implementing the regional CMC regulatory 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 projects yourself and writing global CMC documentation for submissions in line with agreed global regulatory strategy, and within agreed timelines. Writing of submission documents based on technical source reports.
  • Ensuring effective communication of CMC regulatory 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:

  • Motivated and Enthusiastic team player who works well in team but can also work independently. Someone that likes working in a matrix environment across different cultures
  • “Can do” attitude with pragmatic solutions while working within a regulated environment
  • Proven track record of successful authoring and contribution to delivering CMC sections for marketing authorisations/Variations/CTAs for new biological and/or chemical entities.
  • 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 review capacity, with at least 5 years of experience in Regulatory Affairs CMC and preferably 3 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.

 

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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