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Associate Director, Regulatory Affairs

Employer
CK Group
Location
Cambridgeshire
Salary
Up to £80,000 per annum
Closing date
30 Aug 2021

View more

Sector
Regulatory Affairs
Contract Type
Permanent
Hours
Full Time

Job Details

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.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Company info
Website
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB

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