(RA): Submit new dossiers for health products to authorities in South Africa and other markets (Namibia, Botswana material in compliance with legislation; submit to authorities as needed. Renew all registrations according assist with GMP in-house training. Act as an authorized representative for medical devices. B. Pharm
(RA): Submit new dossiers for health products to authorities in South Africa and other markets (Namibia, Botswana material in compliance with legislation; submit to authorities as needed. Renew all registrations according assist with GMP in-house training. Act as an authorized representative for medical devices. B. Pharm
compliance with the relevant Health Regulatory Authorities (Country Specific where applicable in Africa)
regulations in Africa.
Experience with regulatory authorities in sub-Saharan Africa and French Speaking Africa
regulatory affairs or experience at a health authority
Knowledge of regulatory procedures and legislation
and strategies.
Influences Regulatory authorities through regular contacts to improve Regulatory
compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines applications for submission to the regulatory authorities Work in collaboration with internal and external maintain effective relationships with Regulatory Authorities, internal and external stakeholders Formulate
Health Products Regulatory Authority (SAHPRA) and other relevant authorities. Manage timelines for regulatory Communication: Act as the primary contact with regulatory authorities, responding to queries and providing additional
Health Products Regulatory Authority (SAHPRA) and other relevant authorities. Manage timelines for regulatory Communication: Act as the primary contact with regulatory authorities, responding to queries and providing additional
update of documents to be submitted to regulatory authorities, this includes the compilation of Common Technical customer (both internal and external) and regulatory authority queries Ensuring that annual product quality reviews
update of documents to be submitted to regulatory authorities, this includes the compilation of Common Technical customer (both internal and external) and regulatory authority queries Ensuring that annual product quality reviews
Managing and coordinating response to the regulatory authority. Maintain regulatory knowledge of the various
Managing and coordinating response to the regulatory authority. Maintain regulatory knowledge of the various