Regulatory Affairs Executive

Location
Berkshire
Salary
30,000 - 40,000
Posted
10 Jan 2019
Closes
07 Feb 2019
Ref
BBBH23904
Discipline
Regulatory Affairs
Contract Type
Permanent
An exciting opportunity has become available for an experienced and enthusiastic Regulatory Affairs Executive / Senior Regulatory Officer, 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.

Responsibilities:
• 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
o Variations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions
o Reclassification of Medicines
o Re-baseline / Remediation dossiers
o License Transfers (giving away and bringing in) including the due diligence of dossiers
o Maintenance of Marketing Authorisations including renewals
o 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
• 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.

Required Skills:
• Pharmacy/Chemistry degree
• 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 +44(0)1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

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