· 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 · Core competencies · Experience in use of CTD software builder and compilation of eCTD dossier applications. · IT skills including Microsoft Office · Ability to prioritise and work to tight deadlines · Systems and operations analysis · Basic cost management skills · Active learning · Strategic thinking · Ability to cope with a high degree of complexity and change · Cross Functional skills: Ability to network, liaise and negotiate with others · Ability to set standards and objectives and monitor progress · Complex problem solving and decision-making skills · Customer relationships · Development of people · Must demonstrate responsibility, excellence and collaboration and align with Company values · Bachelors Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council · -5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory · activities. · Demonstrable experience across the product development, commercialization and maintenance lifecycle · Sound project management capabilities · Proven ability to consistently deliver to quality, time and cost standards · Good Manufacturing Practices (GMP) · Pharmaceutical production experience or exposure to supplement regulatory knowledge.