An exciting opportunity has arisen for an experienced and enthusiastic Regulatory Affairs Executive to join my client based in Berkshire. This role will focus on post-approval activities across the UK and will offer exposure to many aspects of Regulatory compliance as well as the opportunity to supervise and guide a team.

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 extensionsReclassification of MedicinesRe-baseline / Remediation dossiersLicense Transfers (giving away and bringing in) including the due diligence of dossiersMaintenance of Marketing Authorisations including renewalsDeficiency responses to authoritiesPartake in the interfacing with regulatory authorities to facilitate the approval of submissionsAct as a point of contact for other business units, customers, and internal/external teamsStay informed about new and changing regulatory requirements and ensuring complianceAssist in coaching and mentoring junior members of the teamLiaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome.

Required Experience:

Pharmacy/Chemistry degree A background in R&D and manufacturing industriesSignificant 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.

For further details, please contact Tim Barratt on (phone number removed) or email (url removed)