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SENIOR CONSULTANT REGULATORY AFFAIRS CMC

LOCATION

UK

EMPLOYMENT TYPE

Permanent

Posting Date: 12.12.2023

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We have a new, permanent role for a Regulatory Affairs CMC specialist based in the UK.
 

Our client is a leading specialist consultancy providing regulatory support to global pharmaceutical and biotechnology clients across the full life cycle and in a variety of therapeutic areas. With centuries of combined regulatory experience and established reputation, this is a growing company that offers a great place to work and develop you career. The culture is one of support and inclusion and offers an environment of professionalism and mutual respect, where employees can excel and grow based on merit.
 

This role will lead and support a client with small molecules coming up in development for EU submissions as well as major variations for established products, before moving on to other projects.
 

Responsibilities:

  • In this role you will provide Regulatory CMC expertise and write IMPDs for specific molecules as well as support a new MAA as part of a team.

  • Responsible for assigned projects, leading, and supporting Regulatory CMC submissions in the EU for products in development.

  • Be responsible for managing the Reg CMC aspects of Health Authority interactions.
     

In return you will:

  • You will work alongside and be supported by experienced Regulatory CMC professionals in an environment dedicated to driving and celebrating personal growth.

  • Flexibility to work remotely and earn a competitive industry salary, with a bonus and various company benefits.
     

Skills crucial to success in this role:

  • 3+ years of relevant Regulatory CMC experience.

  • You would have experience in authoring and contributing to timely delivery of RA CMC submission documents – IMPDs, MAA, NDA etc.

  • Experience working on late-stage development projects, as well as experience in communication and negotiation with Health Authorities on RA CMC matters.
     

How does this sound?

Get in touch for more information or click on the apply button below to send us your CV or to register your interest.
 

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