A dynamic pharmaceutical manufacturing company is currently looking for a Design Responsibility – Project Manager to enhance the regulatory portfolio and coordinate technology transfer in their Port Elizabeth Unit. (Fixed term contract of one year, with the potential to become permanent). Duties:

  • To be responsible for technology transfer and the respective project coordination.
  • To cooperate with responsible Regulatory Bodies.
  • To coordinate tech transfer processes within the plant ensuring timely implementation and reporting.
  • Ensure approval of registration applications of all products in applicable countries.
  • Ensure the maintenance/ update of registrations in accordance with the relevant legislation, regulations and guidelines.
  • Compilation of registration dossiers for submissions.
  • Ensure that the local Regulatory Affairs unit applies the latest Procedures and Guidelines as published.
  • Ensures that the overall corporate databases for these countries are kept up to date.
  • Establish and maintain effective relationships with all stakeholders.
  • To enhance and optimize the regulatory portfolio by strategically analyze the files in what regards but not limited to harmonization, suppliers, batch size, specs, test methods etc.; in cooperation with planning, production, QC, Market Unit and other stakeholders.

 Qualifications and Experience:

  • Degree or National Diploma in Science, Quality, Pharmacy, Pharmaceutical Sciences.
  • Direct experience on regulatory affairs in South Africa.
  • Direct experience or contact with pharmaceutical manufacturing environment and technology transfer processes is a plus.
  • 5-10 Years of previous pharma experience.
  • Experience / strong interest in product problem solving and product research and development.
  • Can do attitude.

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