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Regulatory Affairs Executive

Description

CK Clinical are recruiting for a Regulatory Affairs Executive to join a niche organisation that focuses on respiratory and rare diseases based at their offices in Manchester on a permeant basis

Regulatory Affairs Executive Role:

  • Preparation and submission of applications for new Marketing Authorisations, renewal, variation and change of ownership to the Regulatory Authorities in a timely and accurate manner, taking into consideration commercial needs.
  • Prepare responses to questions issued by the Regulatory Authorities.
  • Follow up with Regulatory Authorities on submissions and regulatory issues.
  • Request, review and submit all PSURs as required.
  • Direct negotiations and liaisons with 3rd party companies and other departments of the company concerning submission applications.
  • Keep up to date with the latest guidelines and legislation, advising colleagues on implications of any changes.
  • Maintain smooth running of the regulatory department and the licensing update processes.
  • Where appropriate, draft SOPs/Working Instructions for review prior to final approval and issue.

Your Background:

  • Have hands on experience ion a regulatory environment.
  • Good working knowledge of process linked to legislation and dossier formatting.
  • Strong organisational skills.
  • Time management and the ability to meet deadlines.

Apply:For more information or to apply for this Regulatory Affairs Executive position, please contact Rob Angrave on 01438 870022 or email [email protected], quoting job ref 48490.

It is essential that applicants hold entitlement to work in the UK.

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Manchester, England, Greater Manchester, M2, United Kingdom

  • Ad ID:  15720332
  • Ad Type:  Offered
  • Posted on:  15/09/2020, 02:58
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