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

• 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 primary contact for local health authorities on delegated products.
• Manage advertising material compliance with marketing codes.
• Handle dossier submissions and variations using Docu Bridge for SAHPRA uploads.
• Coordinate with suppliers to ensure accurate and updated dossier information.

• Bachelor of Pharmacy (BPharm); MSc advantageous.
• Minimum 3 years in Regulatory Affairs.
• Proficiency with Docu Bridge and SAHPRA portal submissions.
• Skilled in managing dossier sequences and lifecycle activities.
• Familiarity with biological products is a plus.
• Strong competencies in compliance, accuracy, communication, and problem-solving.

Living the Gen-Eye® CARE values:
Accountability (A),
Respect (R),
Ready to make an impact (Q).

Ready to make an impact? Apply now and help us bring life-changing medicines to market faster!

Mid‑Senior level

Full-time

Information Technology, Analyst, and Product Management

Pharmaceutical Manufacturing and Medical Practices