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Regulatory Submissions Specialist - 63890


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Job Ref: J22876
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 20 July 2017
  • Uxbridge, Middlesex, England, UK
  • n/a
  • Natasha Rollason

The Role:

Responsible for the coordination of all First Registrations, Renewals, Tenders, Response to questions and Site Registrations submissions. Ensuring delivery to agreed timelines and in accordance with priorities defined by the Local Operating Countries and Commercial.

Key Responsibilities:

  • Coordinates the preparation of regulatory submissions (Renewals, Product Expansion Dossiers for Emerging Markets, Site Registrations, Tenders)
  • Monitor plans for upcoming submissions
  • Check with the relevant groups to understand ongoing regulatory activities that may affect the submission package, agree and document strategy.
  • Liaise with documentation suppliers to ensure components are delivered in a timely fashion.
  • Maintain knowledge of relevant submission formats and outputs and guidance associated with different formats of regulatory submissions which may differ with each Authority.

Skills/Experience Required:

  • Industry knowledge of Regulatory Affairs
  • Understanding of Submissions process
  • Project Management experience essential

If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

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