Regulatory Affairs Specialist

3 weeks ago


Johannesburg, Gauteng, South Africa Ultra Personnel Full time
Job Description for Regulatory Affairs Pharmacist

Key Responsibilities:

  • Ensure timely initiation and management of the registration process for new product submissions
  • Ensure approval of registration applications of all medicines with the relevant authorities
  • Complete specific pre-registration activities including receipt, screening, compilation and timeous submission of dossier/s Regulatory Authority
  • Ensure that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to enable registrations
  • Ensure that required standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers are followed after signing of appropriate agreements
  • Ensure the maintenance/ update of registrations in accordance with the relevant legislation, regulations and guidelines
  • Receive, prepares and submits all applicable updates, variations, resolutions and any other correspondence required by the Regulatory Authority
  • Complete dossier audits of Registered Products for the assigned products
  • Conducts dossier due-diligences, post-registration variations for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and applicable Regulations within the specified time-lines in order to support the business and strategic company objectives

Core Competencies:

  • Attention to detail
  • Knowledge of the Regulatory requirements for medical products in South Africa and other applicable territories
  • Project management skills
  • Leadership skills
  • Ability to prioritise and work to tight deadlines
  • Systems approach
  • Cross Functional skills: Ability to network, liaise and negotiate with others
  • Ability to set standard and objectives and monitor progress
  • Problem solving and decision-making skills
  • Sound project management capabilities


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