Job Description
Job Purpose:
Support the Regulatory Affairs team to provide superior Regulatory services to relevant departments within the company and with external Partners and Principals, and to control and manage a portfolio of product outputs. To ensure legal and regulatory compliance with the relevant medicine Regulatory Authorities (country-specific where applicable), Medicines and Related Substances Control Act, and South African Pharmacy Council, ensuring timeous processing of regulatory applications.
Key Job Outputs:
- Manage work streams for, and report on the assigned portfolio of products:
- Assisting with internal product queries from relevant departments
- Assisting with external product queries from the SAHPRA, other MRA's and third-party stakeholders
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submission of materials to ensure timelines, accuracy, comp...