Job description Posted 01 November 2022

Regulatory Associate

Department: Non Clinical Regulatory

Location: Ware – 3 days pw

12-month contract

My Client is looking for a Regulatory Associate, to assist in the preparation of the nonclinical content for various global regulatory dossiers.

Basic qualifications:

  • Minimum graduate level, with a relevant biologically based scientific background. 
  • Understanding of the nonclinical content related to in vivo and in vitro testing: ie pharmacology, pharmacokinetics & toxicology related to drug development
  • Excellent written and verbal communication skills,
  • Competent in the use of Microsoft Word and Excel.
  • Proficiency in searching on-line scientific publication databases.

Preferred qualifications:

Knowledge of nonclinical regulatory requirements [e.g., Common Technical Document (CTD) guidelines] would be preferable but not essential.

Specific Accountabilities and Responsibilities

This role will support both GSK’s extensive portfolio of marketed medicines and vaccines products and also new development assets, managing multiple products in parallel; aligned to departmental priorities and timelines. The role involves collation and update, where required, of nonclinical documentation for the purpose of generating dossiers to support a range of global regulatory submissions including:

  • Registration of approved products in new markets
  • Clinical Trial Applications
  • Licence Renewals
  • Market specific rebaseline dossiers

Activities include:

  • Data mining of nonclinical study reports from legacy systems, submissions and company archives
  • Upload of nonclinical study reports and associated electronic data package (SEND) files in a submission ready format
  • Preparation of status reports in relation to nonclinical studies to facilitate future submission preparation
  • Collation and hand-off of nonclinical summaries and reports to support regulatory submissions
  • Managing copyright clearance for appropriate use of published literature supporting nonclinical regulatory dossiers
  • Collaboration with nonclinical development and regulatory content delivery departments
  • Active participation in departmental meetings to discuss status and prioritization of activities and issues
  • Update of appropriate tracking/scheduling documentation
  • Comprehensive literature/information searches both externally and internally (specified GSK databases).
  • Preparation or collation of nonclinical documentation to meet Market Specific Requirements eg Non EU-Environmental Risk Assessments; Gap Analysis tabulations
  • Compiled eCTD nonclinical component quality checks
  • Responding to requests for nonclinical documentation in a timely manner.
  • Other nonclinical regulatory supporting tasks that may be required from time to time.

If you feel you would be suitable, please send in your CV