Regulatory Affairs - CTA

Job Ref: J23074
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 03 August 2017
  • Berkshire, England, UK
  • n/a
  • Natasha Rollason

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The Role:

To provide operational support to ensure Clinical Study deliverables are achieved across the EEMEA team, will include supporting area and affiliate colleague responsible for development compounds with strategic and operational advice.

Key Responsibilities:

  • Responsible for advice on: submission strategies (VHPs v National Procedures), Safety Reporting, GCP and Safety Issues and local and country specific requirements.
  • Attend CTA Submission team meetings EEMEA team representative.
  • Manage a portfolio of CTAs including preparation of documentation for new CTAs and CTA maintenance.
  • Provide input to CA and EC Responses.
  • Ensure all CTA processes are followed within agreed timelines.
  • Management of databases and activity trackers
  • Support SOP reviews and updates as required.

Skills/Experience Required:

Education

  • Life Sciences Degree qualified.

Knowledge

  • Extensive experience within EU CTA's and associated Regulatory CTA activities.
  • Working experience within VHP is preferable.
  • Ability to work Cross Functionally.
  • Exposure across the EEMEA within obtaining Regulatory approval for CTA's.

If you are interested in this role or would like to have a confidential career 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.