Regulatory affairs specialist

Gen-Eye (Pty) Ltd is seeking a Regulatory Affairs Specialist to join our dynamic team. This role is critical in managing regulatory submissions and lifecycle activities for pharmaceutical products, ensuring timely and compliant registration with SAHPRA and other authorities.

Location: Midrand, Gauteng, South Africa

What You’ll Do Initiate and manage timely registration processes for new product submissions. Ensure approval of all medicine registration applications with relevant authorities. Submit and track dossiers to health authorities for efficient registrations. Build and maintain strong relationships with regulatory authorities for streamlined applications. Implement, audit, and manage regulatory systems effectively. Prepare, review, and comply with SOPs and local regulatory guidelines. Oversee lifecycle management (LCM) and maintenance activities for assigned products. Update local PI and labeling and communicate changes to Marketing and licensors. Act as primar...