Senior Regulatory Affairs Pharmacist

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.

Job Reference
Job Location
Western Cape
DI Pharmaceutica (Pty) Ltd
Job Type
Date Posted