Medicine Registration Officer: Clinical Preregistration Evaluation at South African Health Products Regulatory Authority

REQUIREMENTS:

• A matric certificate and a 4-year degree in Pharmacy or a 4-year degree in Health-Sciences-related field (NQF Level 8) as recognised by the South African Qualification Framework (SAQA). Registration with the South African Pharmacy Council (SAPC) where applicable is required. A relevant NQF level 9 qualification in Health Sciences will be an added advantage. 

EXPERIENCE:

• A minimum of three (3) years' relevant post-internship experience.

COMPETENCIES, KNOWLEDGE, AND SKILLS:

• Knowledge and application of the Medicines and Related Substances Act No. 101 of 1965 as amended, and its related Regulations, concerning the regulation of medicines with respect to quality, safety, and efficacy. Knowledge of the technical aspects and evaluation processes relating to the quality efficacy and bioequivalence of medicines. Comprehensive knowledge and understanding of relevant legislation, regulatory guidelines, protocols, standard operating procedures (SOPs), and work instructions applicable to SAHPRA’s regulatory environment. 
• Possess good planning, organizational and interpersonal skills. 
• Self-motivated and can work without supervision. 
• Have good communication skills (written, and verbal) and ability to negotiate, solve conflicts and prepare presentations. 
• Ability to come with innovations, initiate, and demonstrate assertive and leadership qualities. 
• Be dedicated and pay attention to details. 
• Ethical and maintain high level of integrity. 
• Must be willing to travel and work beyond normal working hours. 
• Must have good customer service. 

DUTIES:

Evaluation of new applications and peer-reviewing of new applications/variations: 

• Must produce evaluation reports for new applications and submit them for peer review as well as ensuring compliance with prescribed templates and existing regulatory /scientific standards (depending on the type of application, i.e., Full/partial reviews Q-BE and Reliance. 
• Evaluate Type I and II applications for clinical or quality variation. 
• Follow peer-review process, amend reports to generate a list of queries that will be shared with applicants using prescribed templates (Full/partial reviews Q-BE and reliance). 
• Review other evaluators’ reports according to the prescribed templates and accepted regulatory /scientific standards (Full/partial reviews Q-BE and reliance) 
• Evaluate PI/PIL applications (new applications and responses). 
• Prepare query or feedback to the applicant (approval or rejection letter). 

Evaluate applicant responses for registration/approval of medicines: 

• Produce another evaluation report for application reviews. 
• Follow peer-review process, amend reports to generate a list of queries that will be shared with applicants, where applicable. 
• Review other evaluators’ reports according to the prescribed templates and accepted regulatory /scientific standards. 

Develop and update guidelines, SOPs, and templates: 

• Review existing guidelines, Standard Operating Procedures (SOPs) and templates and update them when necessary. 
• Train new Medicine Registration Officers (MROs) and external evaluators, and attend workshops about latest guidelines, SOPs and templates. 
• Develop new guidelines, SOPs, and templates where applicable. 
• Submit work plans and targets to the Business Unit Manager (qualitative and quantities report). 
• Perform other duties that a senior manager or Business Unit manager may assign to you. 

Participate in technical working groups or special projects and provide support to the Business Unit as well as to the Advisory Committees: 

• Prepare report for the internal working groups and/or advisory committee. Present at advisory committee for complex scientific matters and ensure adherence to SOPs and Guidelines. 
• Provide quality assurance to reports and facilitate resolutions on technical matters. 
• Align with ICH, WHO, IPRP, international standards, SAHPRA QMS requirements and use the most current SAHPRA templates and guidelines. 
• Execute recommendations from the advisory committee timeously. 

Provide technical advice and information to all stakeholders (internally and externally): 

• Attend to queries from various stakeholders. 
• Provide technical advice and information to all stakeholders. 
• Attend to queries from the Manager, Senior Manager, other Programmes, the legal unit and the Chief Regulatory Officer’s office. 

Technical screening of applications for the registration of medicines: 

• Produce evaluation reports for technical screening of applications and submit them for review. 
• Comply with the report review process and amend technical screening report to generate queries for the applicant using correct templates. 
• Review technical screening reports compiled and reviewed by other colleagues or peers.
• Prepare screening feedback to the applicant (Rejection or approval letter). 
• Provide quality assurance to reports and facilitate solutions to technical matters. 

Closing Date: Friday, 05 August 2026