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.
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.
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.
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
Website: CK Group
- Posted: 7th July 2021
- Expires: 4th August 2021