Associate Director, Regulatory Affairs

  • Salary: Up to £80,000 per annum
  • REF Number: 00050069
  • Consultant: Andy Leake
  • Contact: 01438 842 966
  • Date Published: 02.08.2021
  • Sector:
  • Location: Remote in UK, Home/Field Based
  • Discipline:

CK Clinical are recruiting for an Associate Director, Regulatory Affairs to join a leading Consultancy. This is a permanent position to join an award-winning Regulatory team. Remote working can be considered in the UK.

Associate Director, Regulatory Affairs Role: As Associate Director, Regulatory Affairs you will independently lead regulatory projects in a client-facing position. This will involve developing regulatory strategy for novel cell and/or gene therapies.

Key duties will include:

  • Providing expert strategic advice to clients, considering regulations and guidelines relevant to their products.
  • Preparation of regulatory submission documents including orphan drug designation applications, scientific advice briefing documents, CTA/INDs, paediatric investigation plans, PRIME/BTD and MAA/NDAs.
  • Leading regulatory agency interaction and negotiations.
  • Providing support to the wider business, potentially including mentoring and business development.
  • Being a leaderin developing new procedures/processes for complex projects.

Your Background: As Associate Director, Regulatory Affairs you will require:

  • At least a Life Sciences degree.
  • Proven Regulatory Affairs experience within the pharmaceutical industry and product development. Experience within consultancies is a bonus.
  • Experience working with Cell/Gene Therapies or Biologics is essential.
  • Extensive experience leading the development of Regulatory Strategy. Pre-approval experience is preferred.
  • Strong experience with EU submissions and regulations. US experience is also a bonus.
  • Ability to lead Health Authority interactions.
  • Self-starter attitude, with the ability to independently find creative solutions for complex problems.

Apply: For more information or to apply for this Associate Director, Regulatory Affairs position, please contact Andy Leake on 01438 842966 or email aleake@ckgroup.co.uk, quoting job ref 50069.

It is essential that applicants hold entitlement to work in the UK.

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