Senior Regulatory Affairs Manager
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, lead the development and implementation of new regulatory strategy, and will support Clinical Trial and Manufacturing initiatives across the company.
- Devise and implement regulatory strategy for a range of programmes.
- Overall management of CTA/IND submission activities for EU and US.
- Provide expert advice to development programmes.
- Ensure all programmes are compliant to relevant regulations and standards.
- Develop and maintaineffective relationships with Health Authorities.
- Overall team and line management.
- At least a University degree in a scientific discipline.
- Extensive Regulatory experience within the pharmaceutical industry, mainly within development and clinical trials.
- Proven ability to independently develop and implement regulatory strategy.
- Proven ability to lead and manage regulatory teams.
- Demonstrated experience managing CTA and IND processes.
- Experience workingwith Orphan Drugs or Rare Diseases is preferable.
To apply: It is essential that applicants hold entitlement to work in the UK. For more information or to apply for this Senior Regulatory Affairs Manager position, please contact Andy Leake on 01438 842 966 or email@example.com. Please quote reference 49957.