Reporting to Regulatory Affairs Manager
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
- Sound project management capabilities, with understanding of the medicines value chain
- Proven ability to consistently deliver to quality, time and cost standards
- 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, comprehensiveness, or compliance with regulatory standards
- Artwork reviews and approvals
- 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
- Conduct dossier due diligence to ensure all data gaps are addressed
- Prepare the registration applications for submission to the regulatory authorities Work in collaboration with internal and external stakeholders to assess regulator’s submissions requirements
- Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
- Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
- Internal training and mentoring
- 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, including reporting and metrics management.
- Support activities such as internal audits or regulatory agency inspections
- Ensure alignment of personal and company values