Technical Screener: HPA (Ref 44/2025) at South African Health Products Regulatory Authority

REQUIREMENTS:

• Matric certificate and an appropriate 3-year Bachelor of Science Degree at NQF
• level 7 as recognised by SAQA (Appropriate 4-year degree in Chemistry/Pharmacology or Bachelor of
• Pharmacy will be an advantage), and registration with a statutory council if applicable. Three (3) years of relevant regulatory experience. Experience in product review or assessments will be an added advantage.

COMPETENCIES:

• Knowledge and good understanding: Theoretical knowledge of technical aspects for the evaluation of medicines across all fields, namely: Medicines and Related Substances Act (101 of 1965). Safety and efficacy. Quality and bioequivalence. Naming and scheduling. Good
• Manufacturing Practice. Knowledge of the regulatory environment. Good Clinical Practice.
• Pharmacovigilance.

Skills: 

• Comfort working with computers and computer software packages. 
• Displays a strong

academic background. 

• Good and effective communication skills (written and verbal). 
• Planning and coordination skills. 
• Conflict management. 
• Critical thinking and problem-solving skills. 

Self Management.

• Attributes: 
• Able to remain self-motivated with the ability to work independently. 
• Positive attitude. 
• Team player. 
• Ability to work precisely and efficiently. 
• Ethical behaviour and adherence
• to the SAHPRA Code of Conduct. Flexible. Deadline driven. Honest. Ability to prioritise and display
• excellent time management skills. Ability to work under pressure. Ability to tolerate stress.
• Responsiveness. Relationship management.

DUTIES: 

• Technical screening of medicines applications: 
• Assess each module of the application
• against the relevant technical screening form to ensure they are appropriate in terms of format and
• content as defined by the relevant guidelines.
• Generate a validation report