In the context of a new project, we are looking for our next Regulatory Affairs Officer to join our teams.

Group 10
Responsibilities

  • Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
  • Gain regulatory authority approval
  • Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
  • Provide regulatory support to clients and associate companies
  • Liaise with external regulatory authorities as required
  • Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling
  • Review tasks for, support and mentor Regulatory Affairs Associates

Group 13
Profile

  • Bachelor’s or higher graduate degree in a science related field, or equivalent experience.
  • 2 to 5 years of experience in a regulatory affairs department required
  • Relevant experience in International  region regulations (can be MENA, Africa, APAC etc..)
  • 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 in English
  • Good computer skills and the ability to learn appropriate software (eDMS, MS Word, MS Excel)

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