Duties inclusive but not limited to the below;
- Converting an existing application to eCTD format.
- Preparation and submission of Sunset clause, MA cancellation applications, MA transfers, remediation dossiers as required by the Company.
- Ensure completion of post-approval commitments, if any.
- Compilation and maintaining Product licence files.
- Co-ordinate regulatory activities with QPPV and QP (Quality/GMP) for management of MAs.
- Have a good understanding of and be able to execute activities related to the following key areas
- Variations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions
- Reclassification of Medicines
- Re-baseline / Remediation dossierS
- Prepare and submit applications of reliable quality in a timely manner to MHRA (UK) via National Procedure. These include new licence applications, variations (including grouping and work sharing), renewals, artwork changes, RFIs, updates and any other relevant applications or notifications.
- Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
- Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
Experience with Generic products and MRP/DCP submissions is advantageous
Please contact Liam Smith at Science Solutions