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Regulatory CMC Scientist

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Regulatory Affairs
Job ID:  65199

 

Regulatory CMC Scientist -Biologics

Global Regulatory Affairs

Location: Slough, UK

 

Help us transform patients’ lives.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

 

To strengthen our Global Regulatory Affairs team, based in our site in Slough, UK, we are looking to fill the position of: Regulatory CMC Scientist -Biologics .

 

Are you analytical with innovative capacities? At UCB that makes you an ‘analyvative’ person. This unique blend of talent means you are good at processing facts to forge new solutions for patients.

 

As a UCB 'analyvative' person and Regulatory CMC Scientist -Biologics you like to work in an environment where you can:

  • • Take responsibility for the regulatory CMC support of Biologica products throughout the 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 Scientist and agreed with the GRA Practice Leadership Team and the operating units

 

As a UCB 'analyvative' person and Regulatory CMC Scientist -Biologics you will contribute by:

 

  • 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 in line with agreed global regulatory strategy, and within agreed timelines
  • Provide strategic planning expertise relating to all global artwork implementation into production
  • Ensuring effective communication of CMC regulatory strategy, risks, and overall plan for assigned regions to GRA Practice Teams, TSO Practice Teams and PVUs as agreed with the Global Regulatory CMC Lead

 

Interested? For this position you’ll need the following education, experience and skills:

 

  • Educated to a Masters level, in a relevant life sciences or business related discipline
  • At least 5-8 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 3years 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
  • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
  • Extensive experience of direct communication and negotiation with regulatory agencies on CMC matters
  • Extensive active participation in regulatory agency meetings on CMC matters
  • Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
  • Demonstrated competence in contributing on cross-functional teams and operating within a matrix organisational structure
  • Excellent interpersonal skills

To apply please go to www.ucb.com/careers.

Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers.


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