Regulatory Affairs Associate

Job Ref: J29123
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 02 November 2018
  • Berkshire, England, UK UK
  • Competitive
  • Natasha Rollason

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The Role:

To provide administrative support to members of the department and Head of Regulatory Affairs and QA and to provide export certificates (as applicable).

Key Responsibilities:

  • Assist with the preparation of regulatory submissions
  • Assist in organisation, document preparation & minute taking for Medical Division Audits and Inspections
  • Upload SmPCs and PILs on to eMC where applicable
  • Assist department to copy and send out documents/CDs to MHRA as required
  • Coordination of departmental projects
  • Perform quarterly audits on AbbVie SmPCs on eMC website and report any discrepancies
  • Provision of Export Certificates as required
  • Process PLPI requests as required
  • Preparation of Status Reports and metrics
  • Daily checking of Regulatory Affairs NORS/NORA in-box

Skills/Experience Required:

Previous experience in a similar role within a complex organisation

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

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.

02/12/2018 11:10:33