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Senior Regulatory Manager (EAP)

Hertfordshire   •  Permanent, Full time


CK Group is recruiting for a Senior Regulatory Affairs Manager to join an Early Access Program Team within a global CRO. This will be based in Hertfordshire, Oxfordshire or Derbyshire with flexible home working available.

RESPONSIBILITIES:
As a Senior Regulatory Affairs Manager, you will manage and execute day-to-day Regulatory activities for global Early Access Program (EAP) projects.

Key duties will include:
- Lead Regulatory strategy and operational advice to clients.
- Act as client main point of contact for specific projects.
- Lead interactions with health authorities.
- Lead operational activities for specific EAP projects, including supporting activities to get specific treatments to specific patients around the globe.
- Ensure compliance to relevant regulations and procedures.

QUALIFICATIONS:
As a Senior Regulatory Affairs Manager you will require:
- At least a University Degree in a relevant scientific discipline.
- Proven experience in Regulatory Affairs in an EAP is ideal. Strong general regulatory experience is also okay.
- Strong experience leading client and health authority interactions.
- Experience writing and reviewing regulatory documents.
- Experience with Regulatory strategy.
- High attention to detail and excellent communication skills.

Apply:
Entitlement to work in the UK is essential. Please quote reference 51062 in all correspondence.


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Andy Leake
  • Phone: 01438 743047
  • Reference: 51062
  • Posted: 7th July 2021
  • Expires: 4th August 2021

CK Group

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