Job Purpose
- Support the Regulatory 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.
- Manage work streams for- and report on the assigned portfolio of products:
- Internal product queries from relevant departments
- External product queries from the SAHPRA, other MRAs and third party stakeholders
- Establish regulatory priorities and allocate resources and workloads
- Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards
- Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to
- Develop regulatory strategies and implementation plans for the preparation and submission of new products, with a focus on complementary medicines and medical devices.
- Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines and other human medicines.
- Prepare the registration applications for submission to the regulatory authorities
- Work in collaboration with internal and external stakeholders to assess regulators submissions requirements
- Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines for variations (CMC & Labelling), Renewals, Artwork updates etc.
- Update and maintain databases, trackers and systems for all regulatory related activities.
- Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained.
- Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
- Internal training and mentoring of peers when required.
- Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
- Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Support activities such as internal audits or regulatory agency inspections
- Ensure alignment of personal and company values
