Key Responsibilities:To have an in-depth scientific and regulatory knowledge of the therapeutic area and regulatory landscape in Europe, Turkey, Israel and Switzerland providing comprehensive regulatory...
To provide administrative support to members of the department and Head of Regulatory Affairs and QA and to provide export certificates (as applicable).
- Assist with the preparation of regulatory submissions
- Assist in organisation, document preparation & minute taking for Medical Division Audits and Inspections
- Upload SmPCs and PILs on to eMC where applicable
- Assist department to copy and send out documents/CDs to MHRA as required
- Coordination of departmental projects
- Perform quarterly audits on AbbVie SmPCs on eMC website and report any discrepancies
- Provision of Export Certificates as required
- Process PLPI requests as required
- Preparation of Status Reports and metrics
- Daily checking of Regulatory Affairs NORS/NORA in-box
Previous experience in a similar role within a complex organisation
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 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.