Description:
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.
Requirements:
- B.Pharm Degree: 5 to 6 years
- Pharmacist Registered With SAPC: 5 to 6 years
- Lorenz Docubridge Program: 5 to 6 years
Required competencies and skills:
· B.Pharm Degree, registered as a Pharmacist with SAPC with a minimum of 5 years experience.
· Advanced knowledge of the CTD dossier and technical information (comparative dissolution studies, bioequivalence studies, validation and qualification, specifications, and methods, etc.) is required.
· Understanding of the Regulatory Authority guidelines, and relevant Acts and Regulations.
· A solid foundation in regulatory tasks, complemented by sufficient knowledge and comprehension of the duties.
· Experience in the Lorenz Docubridge program (eCTD document management software) would be beneficial.
· Proficient in English (written and verbal skills required).
· Proficient with MS Office (Excel, Word, Power Point).
· Capability to disseminate knowledge and facilitate the training of fellow employees.
Personal attributes:
· Analytical, precise and solution orientated.
· Motivated, energetic and enthusiasm for learning new tasks and expanding knowledge.
· Honest hardworking and self-driven individual with the ability to work independently to meet tight deadlines in a dynamic and fast-paced environment.
· Ability to adapt and work collaboratively with cross-functional team members.