Regulatory Affairs Assistant

ProductLife Group is looking for Regulatory Affairs Assistant to join our dynamic team.

About us

Group 10
Responsibilities

  • To contribute to the production of client administrative documents to be included in regulatory submissions
  • Compile regulatory dossiers in accordance with national requirements.
  • Systems Management and Administration
  • Document and track regulatory submissions and regulatory authority approval.
  • Provide regulatory support to clients and associate companies.
  • Liaise with external regulatory authorities as required.
  • Provide review of packaging texts.
  • Provide format review of Summary of Product Characteristics, Patient Information Leaflets and labelling (e.g. QRD compliance check).
  • Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
  • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services supplied by the platform/hub
  • Assist in the preparation of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs).
  • Assist in the management of ProductLife Ltd’s Quality Management System.

Group 11
Education

  • Bachelor’s degree in a science related field, or A levels with data entry experience

Group 12
Experience

  • Experience of 0-3 years of RA experience

Group 13
Skills

  • Excellent organizational and interpersonal skills
  • Ability to work well within a team
  • Process orientated with good attention to detail
  • Effective oral and written communication skills
  • Good computer skills and the ability to learn appropriate software
  • Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
  • Good English language and grammar skills skills (written fluency a must, verbal fluency preferred)
  • German language preferred

 

Group 10

Regulatory Affairs Assistant 330