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Global Regulatory CMC Scientist

Location: 

Smyrna, Georgia, United States

Job Function:  Regulatory Affairs
Job ID:  65302

 

Global Regulatory CMC Scientist – Biologics

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 CMC Scientist – Biologics.

 

 

What We Offer

An opportunity to:

  • Take responsibility for the regulatory CMC support of Biologic products throughout the product Life-Cycle
  • Define strategy, planning and preparation of regional specific CMC submission documentation for assigned geographical regions 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 Leadership Team and the operating units

 

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 regional and global CMC documentation for submissions (CTA, MAA/BLA/NDA, Variations, supplements) in line with agreed global regulatory strategy, and within agreed timelines
  • Ensuring effective communication of CMC regulatory strategy, risks, and overall plan for assigned regions to GRA Teams, Technical & Supply Operations (TSO) Teams, Development and Commercial Teams as agreed with the Global Regulatory CMC Lead
  • Identifying supporting CMC documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
  • Responsible for regulatory assessments for CMC changes and creation of entries and updates in the designated systems (Track wise, UPILOT, etc.) within defined timelines

 

About You

You should have:

  • Educated to a master’s level, in a relevant life science or business-related discipline
  • Several years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with suitable experience in Regulatory Affairs CMC and preferably 3 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
  • Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities.

 

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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