The Role: To provide RA leadership on product lifecycle management (change management) and global product registrations. Provide support for initiating and tracking impact assessments for...
To provide operational support to ensure Clinical Study deliverables are achieved across the EEMEA team, will include supporting area and affiliate colleague responsible for development compounds with strategic and operational advice.
- Responsible for advice on: submission strategies (VHPs v National Procedures), Safety Reporting, GCP and Safety Issues and local and country specific requirements.
- Attend CTA Submission team meetings EEMEA team representative.
- Manage a portfolio of CTAs including preparation of documentation for new CTAs and CTA maintenance.
- Provide input to CA and EC Responses.
- Ensure all CTA processes are followed within agreed timelines.
- Management of databases and activity trackers
- Support SOP reviews and updates as required.
- Life Sciences Degree qualified.
- Extensive experience within EU CTA's and associated Regulatory CTA activities.
- Working experience within VHP is preferable.
- Ability to work Cross Functionally.
- Exposure across the EEMEA within obtaining Regulatory approval for CTA's.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.