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.