Regulatory Senior Officer

Regulatory Senior Officer
  • Competitive
  • Temporary
  • Kent, England, UK Kent UK CT13 9ND
Job Ref: J36195
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 07 May 2020
SRG are looking for a Senior Regulatory Officer CMC to work on an initial 6 month contract in Kent working remotely to begin with due...

Our client a Global Pharmaceutical organisation have opened a new vacancy within their Regulatory Affairs team and are actively seeking to recruit a Senior Regulatory Officer CMC to work at their offices in Kent on an initial 6 Month contract basis. This role will be remote working to begin with due to COVID-19.

Key Responsibilities:

  • Prepare high quality Regulatory CMC documentation, with a focus on post approval submissions for the respiratory product portfolio across global territories
  • Conducting GAP analysis and remediation activities for regulatory documentation
  • Responsible for managing multiple concurrent submissions, ensuring tracking of deliverables.
  • Processing change controls for the respiratory portfolio
  • Ensuring high level of quality through review and checking of Regulatory submissions
  • Preparing, assisting and supporting CMC Regulatory related work as directed by supervisor

Skills/Experience Required:

  • Pharmacy, Chemistry or Life Sciences Degree
  • Experience with the preparation Regulatory CMC documents
  • Experience working in Regulatory CMC or related department within pharmaceutical sciences
  • Be able to work as self-starter with minimal supervision
  • Experience working in a Document Management System
  • Proficient in use of Microsoft Word and Excel
  • Proficiency in speaking, comprehending, reading and writing English is required

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673

06/06/2020 12:02:50
Contact Consultant:
Natasha Rollason

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