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Senior Regulatory Affairs Consultant

Website Achieva Group Limited

An excellent opportunity has arisen for a Senior Regulatory Affairs Consultant to join my client, a large biotech based in London.  This role sits within their oncology department and the ideal person will have a strong background within full lifecycle regulatory affairs; CTAs through to registration and post approval.

Responsibilities include:

  • Regulatory management and local regulatory strategy for a portfolio of products
  • Ensure regulatory submissions are timely and meet the clients 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
  • Disseminate relevant information to team(s) as appropriate
  • Participate in local regulatory process improvements initiatives
  • Assist locally in Healthcare Compliance activities where applicable
  • 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 skill

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 01727 817 626 or email

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