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