Duties may include, but are not limited to, the following:
· Methodic and correct implementation of the working methodology of SAHPRA and the South African Pharmacy Council.
· Compilation of new medicine registration dossiers/applications and pre-registration query responses (NCE, OTC, generic, and complementary medicines).
· Evaluate and compile quality variations (NCE, generics and complementary medicines).
· Compilation of clinical safety updates, compilation of new PI/PILs (NCE, generics, and complementary medicines).
· Compilation of technical dossiers (medical devices).
· Compilation of renewal applications to SAHPRA (NCE and generics).
· Renewal of license applications and amendments (Category A & D medicines and medical devices).
· Liaising on a professional basis with SAHPRA, manufacturers, packers, distributors, and laboratories.
· Assistance with maintenance of the quality management system and auditing in accordance with GxP standards & requirements.
· Support QA manager with Change Control systems related to Regulatory variations.
· Assistance with Pharmacovigilance system.