CK Clinical are recruiting for a Senior Regulatory Affairs Manager to join a world leading research company in London on a permanent basis.
Senior Regulatory Affairs Manager Role:
The Senior Regulatory Affairs Manager will provide operational management to the Regulatory Group and through this and other activities support to the Head of Regulatory Affairs.
This role has a focus on supporting the clinical trial and manufacturing initiatives at CGT and as such calls for strong experience in clinical trial submissions and CMC and GMP requirements of product and process development for the EU and US markets.
- Education to degree level or above in Life Science or a related field.
- Significant experience of working within Regulatory Affairs to a Senior level and ideally in the ATMP/cell and gene therapy field.
- Experience in implementing and helping to develop regulatory strategies (ideally for ATMP products) including orphan indications, managing complex regulatory issues and leading the regulatory aspects of the development strategy.
- Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives as well as demonstrable regulatory leadership of IND and CTA processes and experience of scientific advice meetings with Regulatory Authorities.
For more information or to apply for this Senior Regulatory Affairs Manager position, please contact CK Group, quoting reference 48762.
It is essential that applicants hold entitlement to work in the UK.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Amy Lloyd
- Phone: 01438 743047
- Reference: 48762
- Posted: 6th October 2020
- Expires: 3rd November 2020