Associate Director, Regulatory Affairs
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 firstname.lastname@example.org, quoting job ref 50069.
It is essential that applicants hold entitlement to work in the UK.