Regulatory Affairs Manager

SUMMARY:
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POSITION INFO:

The Regulatory Affairs Manager is responsible for ensuring full regulatory compliance in accordance with the Medicines and Related Substances Act (Act 101 of 1965), Pharmacy Act (Act 53 of 1974), and all applicable regulations and guidelines issued by SAHPRA, SAPC and other relevant authorities.

The role provides operational leadership across Regulatory Affairs, Quality Assurance, Pharmacovigilance oversight and regulatory systems, ensuring efficient dossier lifecycle management, strong regulatory relationships, robust compliance systems, and delivery against business growth objectives.

Key Responsibilities:

• Regulatory Compliance & Governance
• Dossier Lifecycle Management
• Stakeholder Engagement
• Quality & Pharmacovigilance Oversight
• Operational Leadership & Performance
• Systems & Data Integrity
• Decision-Making Authority

Behavioural Competencies:

• High ethical standards, integrity and accountability
• Strong leadership and people management capability
• Resilient and solution-oriented
• Excellent communication and stakeholder engagement skills
• Strong organisational and prioritisation ability
• Analytical thinking and decision-making capability
• Strong documentation and compliance systems knowledge
• Assertive, confident and results-driven

Qualifications & Experience:

• Degree in a scientific discipline (pharmacy, biology, chemistry)
• Experience managing cross-functional regulatory portfolios
• Exposure to multi-country regulatory submissions