Regulatory Affairs Specialist

Gen-Eye (Pty) Ltd; Midrand; On-site; ZAR 480,000 - 600,000; Full time

Job summary

A leading pharmaceutical company in Midrand, Gauteng is looking for a Regulatory Affairs Specialist to manage regulatory submissions and lifecycle activities for pharmaceutical products. Candidates should have a Bachelor of Pharmacy and at least three years of experience in Regulatory Affairs. This full-time role requires proficiency with DocuBridge and a strong focus on compliance and communication. The successful applicant will contribute to bringing life-changing medicines to market efficiently.

Qualifications

• Minimum 3 years in Regulatory Affairs.
• Skilled in managing dossier sequences and lifecycle activities.
• Experience with SAHPRA portal submissions.

Responsibilities

• Initiate and manage timely registration processes for new product submissions.
• Ensure approval of all medicine registration applications with relevant authorities.
• Build and maintain strong relationships with regulatory authorities.

Skills

Proficiency with DocuBridge

Strong communication skills

Problem-solving abilities

Attention to compliance and accuracy

Familiarity with biological products

Education

Bachelor of Pharmacy (BPharm)

MSc

Tools

DocuBridge

Job description

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

What We’re Looking For

• Bachelor of Pharmacy (BPharm); MSc advantageous.
• Minimum 3 years in Regulatory Affairs.
• Proficiency with DocuBridge 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.

Behaviours

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!

Seniority level

Mid‑Senior level

Employment type

Full-time

Job function

Information Technology, Analyst, and Product Management

Industries

Pharmaceutical Manufacturing and Medical Practices