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An excellent opportunity has arisen for a Regulatory Affairs Executive to join my client based in Berkshire and focusing on cGMP, solid dosage generic pharmaceuticals.
Responsibilities:
- 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.
- 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.
- License Transfers (giving away and bringing in) including the due diligence of dossiers.
- Maintenance of Marketing Authorisations including renewals.
- Deficiency responses to authorities.
- Partake in the interfacing with regulatory authorities to facilitate the approval of submissions.
- Act as a point of contact for other business units, customers, and internal/external teams.
- Stay informed about new and changing regulatory requirements and ensuring compliance.
- Assist in coaching and mentoring junior members of the team.
- Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
Required Skills:
- Pharmacy/Chemistry degree.
- A background in R&D and manufacturing industries.
- Significant Regulatory Affairs experience.
- 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.
