Regulatory Affairs Pharmacist

MAIN PURPOSE OF JOB

• Medicines Registration and Maintenance of Product Licenses with various Health Authorities in African countries

RESPONSIBILITIES

• Responsible for new product applications.


• Compilation and submission of Post –Registration amendments to ensure dossier compliance.


• Responsible for pre and post registration SAHPRA Committee recommendation responses to ensure product registration.


• Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation


• To ensure approval and compliance of printed packaging material and promotional marketing material.


• Liaising with marketing department to facilitate timeous launch of products.


• Approval of master batch documentation prior to product production.


• Responsible for SOP implementation/review, update and compliance.


• Managing and maintaining regulatory docum...