An exciting opportunity has become available for an experienced and enthusiastic Senior Regulatory Executive, to join an exciting new client based in Berkshire! The successful candidate will have a strong background in registration and post approval submissions, and ideally a background within generics.
*Prepare and submit applications to the 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
oVariations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions
oReclassification of Medicines
oRe-baseline / Remediation dossiers
oLicense Transfers (giving away and bringing in) including the due diligence of dossiers
oMaintenance of Marketing Authorisations including renewals
oDeficiency 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
*Assist the RA Manager in coaching and mentoring junior members of the team
*Maintain up-to-date records and documentation in relation to Marketing Authorisations.
*Carry out duties in line with regulatory, commercial, quality and business needs and ensure compliance with regulatory legislation, guidelines, and company processes and procedures.
*Assist in preparation of procedures for relevant regulatory activities, and in preparation and review of procedures for other areas.
*2-3 years 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 about this role, or other vacancies within Regulatory Affairs, please call Tim Barratt on or email a copy of your CV to firstname.lastname@example.org