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Regulatory Affairs Officer

4 months ago

Krugersdorp, South Africa Assign Services (Pty) Ltd Full time

JOB OBJECTIVE:

  • Link between Bio Sciences and regulatory authories ensuring that products are registered and distributed in compliance with appropriate legislation.
  • Technical customer queries and product complaints.
  • Compile product labels
  • Art work and promotional review and approval for regulatory compliance
  • Change control recording and review.
  • Ensuring compliance with current legislation.

 

KEY RESULT AREAS:

  • Renew Product registrations for products registered with Act36 of 1947
  • Be part of the NPD (New Product Development) process and ensure that the SOP is followed which include the request for the production of trial batches for stability testing and trial use
  • Liase with technical manager to assist with the arrangement and testing of new products.
  • Custodian of Master Formulation Sheets.
  • Ensuring that master documentation is updated and current, approved and signed for all products.
  • Compile dossiers for registration or amend registered dossiers with new product information.
  • Ensuring compliance with regulations set by the Regulatory Authorities
  • Liaising and negotiating with regulatory authorities
  • Writing user friendly product information leaflets.
  • Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to.
  • Compiling report to manage and follow-up compliants from Customers and consumers.

 

QUALIFICATIONS AND EDUCATION REQUIREMENTS:

  • Graduate qualification in Agriculture/ Horticulture.
  • 3-5 years’ experience in the Agricultural / Horticultural regulatory industry with a demonstrable track record.

KEY COMPETANCIES

  • Regulatory Knowledge of Act36 of 1947
  • Strong attention to detail and accuracy skills.
  • Commercially aware
  • Very Good analytical skills.
  • Problem solving skills
  • Excellent Self management and pritotisation.
  • Ability to work within a team.
  • Strong people skills
  • Good presentation skills
  • Goal oriented .