Associate Director, Regulatory Affairs

Recruiter
CK Group
Location
Cambridgeshire
Salary
Up to £80,000 per annum
Posted
02 Aug 2021
Closes
30 Aug 2021
Ref
50069
Contact
Andy Leake
Contract Type
Permanent
Hours
Full Time
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 leader in 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.