Medicine Registration Officer : Names and Scheduling

South African Health Products Regulatory Authority; Pretoria; On-site; ZAR 300,000 - 450,000; Full time

Job summary

A leading regulatory authority in South Africa is seeking a Medicine Registration Officer to manage applications for drug names and scheduling. The role involves evaluating applications, preparing reports, and providing technical advice to stakeholders. Candidates should have a degree in Pharmacy and relevant experience, with a focus on regulatory processes. This position offers the opportunity to contribute to public health by ensuring compliance and effective management of pharmaceutical products.

Qualifications

• Matric certificate and a four-year degree in Pharmacy required.
• Registration with the South African Pharmacy Council is necessary.

Responsibilities

• Evaluate new applications and proprietary name changes.
• Prepare submissions for schedule amendments approval.
• Respond to queries from stakeholders and provide technical advice.

Skills

Pharmacy

Education

Four-year degree in Pharmacy

Master’s degree

Job description

Job Title: Medicine Registration Officer: Names and Scheduling

Location: Gauteng, Pretoria

Deadline: June 15, 2025

Requirements

• Matric certificate and an appropriate four-year degree in Pharmacy at NQF Level 8, recognized by SAQA, and registration with the South African Pharmacy Council. A relevant Master’s degree is an advantage.

Experience

• Grade 1: Minimum of two (2) years relevant experience post-internship and community service; regulatory experience is an advantage.
• Grade 2: Minimum of five (5) years relevant experience post-internship and community service; regulatory experience is an advantage.

Duties

1. Evaluate the name and schedule of new applications.
2. Assess new application’s PI/PILs.
3. Evaluate proprietary name change applications.
4. Facilitate evaluation of new chemical entities and rescheduling applications.
5. Allocate applications to reviewers and follow up on evaluations.
6. Identify schedules for substances, new chemical entities, authorized prescribers, and update schedules accordingly.
7. Prepare submissions to the Minister of Health for schedule amendments approval.
8. Support and prepare reports/documents for the Names and Scheduling Advisory Committee.
9. Refer applications to advisory committees and implement recommendations.
10. Update standard operating procedures, templates, guidelines, and related documents as per procedures.
11. Prepare documents and presentations for meetings.
12. Participate in discussions during meetings.
13. Respond to queries from stakeholders and provide technical advice.