Regulatory Affairs Project Manager
CK Clinical are recruiting for a Regulatory Affairs Project Manager to join a pharmaceutical company focused on Oncology studies on a permanent basis, who are relocating to the Cheshire area.
The main purpose of the role will be to:
- Project manage regulatory submissions to EMA and interactions with the agency.
- Oversee publishing of all electronic regulatory submissions, including management of external providers.
- Provide guidance on EMA requirements.
- Serve as an EMA correspondent.
- Regulatory submission SOPs and other guidelines, communicating updates and information as appropriate.
- Bachelor's degree in a scientific discipline.
- 5+ years of experience in a regulatory affairs role, including EMA experience.
- Thorough working knowledge of regulatory agency requirements (EMA, FDA) and ICH, with successful experience of global clinical trial and marketing applications.
- Ability to liaise with regulatory agencies.
- Drug development knowledge, with oncology-specific experience highly desired.
- Knowledge of GCP, GMP and GLP.
For more information or to apply for this Regulatory Affairs Project Manager position, please contact Rob Angrave on 01438 870022 or email firstname.lastname@example.org, quoting job ref 48017.
It is essential that applicants hold entitlement to work in the UK.