Regulatory Affairs Pharmacist
1 month ago
We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. This is an exciting opportunity for someone with experience in regulatory affairs, particularly in human medicines, including complementary medicines and medical devices.
As a Regulatory Affairs Pharmacist, you will be responsible for managing work streams for assigned products, reviewing regulatory agency submissions, and coordinating new product applications in South Africa and other territories.
You will develop regulatory strategies, conduct dossier due diligence, prepare registration applications, and maintain existing registrations in accordance with relevant legislation, regulations, and guidelines.
This role requires strong project management capabilities, sound knowledge of Good Manufacturing Practices (GMP), and experience with CTD software builder and eCTD dossier applications.
Key responsibilities include:
- Establishing regulatory priorities and allocating resources
- Reviewing regulatory agency submissions for timelines, accuracy, and comprehensiveness
- Coordinating new product applications and maintaining existing registrations
- Developing regulatory strategies and implementation plans
- Conducting dossier due diligence and preparing registration applications
The ideal candidate will have a Bachelor's Degree in Pharmacy, Registration with the South African Pharmacy Council, and +/- 5 years of experience in regulatory affairs. They must also possess excellent communication skills, ability to prioritize tasks, and work well under pressure.
Salary: R900k - R1m per annum
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