Regulatory Affairs Officer All Levels

3 weeks ago

Maidenhead, United Kingdom Science Solutions Recruitment Ltd Full time

**Responsibilities**

Duties inclusive but not limited to the below;
- 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

**Required Skills**:

- 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

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