Senior Regulatory Affairs Executive

Employer
Key People Limited
Location
Berkshire, England
Salary
£35000 - £40000 per annum + benefits
Closing date
21 Sep 2020

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
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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.

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
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.

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 or email a copy of your CV to tbarratt@keypeople.co.uk

International recruitment solutions

Key People is a truly international operation with offices in the UK, Switzerland and Iraq

We have developed working relationships with many of the FTSE 100 companies, including some of the world's most recognised global brands in the pharmaceutical, Oil, Gas, Energy and engineering industries.

Our dedication to both employers and candidates, and our vast experience enables us to provide superior solutions and effective results. We're proud to be a private company driven by our commitment to our customers and we are constantly exploring new markets in our bid to become the number one recruitment agency for customer satisfaction across a number of industry sectors.

Contact Us
  • Catherine House
  • Adelaide Street
  • St Albans
  • AL3 5BA
  • GB
  • +44 (0) 1727 811634
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