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Regulatory Affairs Consultant

West London   •  £30 - £39 per annum  •  Contract/Temporary, Full time

Within this role, you will work for one of the world?s largest independent biotechnology companies.  My client have discovered and developed innovative human therapeutics, and invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

The role:

  • An affiliate Regulatory Affairs role, the Regulatory Affairs Consultant will be responsible for the local coordination and execution of regulatory submissions in compliance with company corporate standards and national regulatory requirements, and of Regulatory Affairs processes and deliverables for the UK and Ireland.
  • Reporting to the Regulatory Director for UK and Ireland, the core elements of this pivotal role will be to support and execute local and EU regulatory strategy, including the management of marketing authorisations, clinical trial application (CTA) submissions and regulatory support for the UK and Ireland affiliate commercial activities.

Responsibilities include:

  • Regulatory management and local regulatory strategy for a portfolio of products
  • Ensure regulatory submissions are timely and meet the company?s corporate and local regulatory requirements.
  • Contribute to and execute the filing plan for their country where applicable
  • Represent regulatory on cross functional brand or project teams and provide advice on local regulatory and compliance strategy at a local or regional level
  • Review promotional and non-promotional materials
  • Maintain an awareness of and ensure local management are kept up to date on new & developing local legislation & regulatory policy
  • Coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies.
  • Collate, distribute, exchange and archive regulatory information with regulatory colleagues and the affiliate and provide advice on local regulatory considerations in a timely manner.

Basic qualifications:

  • Relevant Bachelor?s degree is essential
  • Experience in/knowledge of developing and maintaining CTA documentation in the EU (e.g. IMPDs, IMPD amendments) and ability to work with some autonomy
  • Knowledge and awareness of the relevant regulatory guidelines and legislation
  • Strong communication skills both oral and written
  • Organizational skills & regulatory project management skills

Preferred Qualifications and Experience:

  • Experience gained within a biologics organisation
  • Experience in review of promotional and non-promotional material in accordance with the UK and Irish industry codes of practice

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk

  • Agency: Achieva Group Limited
  • Reference: BH-33425
  • Posted: 16th June 2022
  • Expires: 14th July 2022

Achieva Group Limited

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