Regulatory Affairs Portfolio Lead

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...