Current Job and Project Opportunities
Posting: FDAAA Posting No. 2021-8
Job/Opportunity: Evaluators for Clinical Assessment of New Chemical Entities and Generics
Organization: The South Africa Health Products Regulatory Authority (SAHPRA)
Seeking Experienced Evaluators for Clinical Assessment of SAHPRA Applications
The South Africa Health Products Regulatory Authority (SAHPRA) is seeking evaluators in the field of clinical to support the SAHPRA Backlog Clearance Programme. While continuing to develop local evaluator capacity, SAHPRA has elected to identify and contract qualified, experienced evaluators due to the scope of the application backlog and the public health need.
This is a specific program to eliminate the backlog of marketing authorization applications (both initial and variations) they inherited from the old Medicines Control Council. SAHPRA is seeking both reviewers of new chemical entities (with clinical safety and efficacy data) and also reviewers of generic drug applications (with clinical bioequivalence data).
- More than 7 years of experience as an evaluator for a national regulatory agency in reviewing and evaluating reports relating to preclinical and clinical studies submitted in support of the labelling of NCE and generic medicines
- Dedicated, hard-working, and able to meet deadlines
- Willing to work a minimum of 15 hours per week as a contractor for SAHPRA
- Able to be contracted as an individual contractor, not through a LLC, consulting agency, etc.
- Access to a personal computer (Windows preferred) with powerful microprocessor (e.g. Intel i5) and reliable Internet connection
SAHPRA will offer a competitive hourly salary and applicants will be able to work flexible hours remotely. SAHPRA can offer up to 40 hours per week of contracted work. The Backlog Clearance Programme is currently scheduled to be completed in December 2021.
Potential applicants are urged to submit their interest as soon as possible.
Interested applicants should submit a cover letter and CV to Mankiti Khaebana (firstname.lastname@example.org) and Puleng Nkosi (email@example.com).