Associate Director, Regulatory Affairs

About the role

The Associate Director, Regulatory Affairs will lead and develop the Regulatory Affairs team in South Africa, defining clear strategic direction and ensuring timely product approvals. This senior role partners with global, regional and local stakeholders to accelerate patient access to medicines while maintaining compliance with all regulatory requirements.

Key responsibilities

• Lead, coach and develop the Regulatory Affairs team, managing talent and departmental budget.
• Develop and execute regulatory strategies to obtain and maintain marketing authorisations, including new applications, variations, renewals and major indications.
• Provide strategic regulatory guidance for product development, launches, business development and market access initiatives.
• Maintain compliance with South African pharmaceutical legislation, SAHPRA requirements and company quality standards.
• Monitor regulatory intelligence, legislative changes and emerging trends, communicating insights to internal teams.
• Build and sustain effective relationships with health authorities, industry associations and external stakeholders.
• Represent Regulatory Affairs during inspections, audits and cross‑functional business initiatives.
• Support clinical trials, safety reporting, labelling, promotional review and other regulatory compliance activities.

Required profile

• Bachelor’s degree in Pharmacy (required).
• Minimum 6 years experience in Regulatory Affairs, including direct engagement with SAHPRA.
• Experience working across Sub‑Saharan Africa is advantageous.
• Sound knowledge of South African pharmaceutical legislation, regulations and guidelines.
• At least 3 years of people‑leadership and team‑management experience.

Required skills

• Strong verbal and written communication.
• Excellent planning, organisational and project‑management capabilities.
• High attention to detail and commitment to quality and compliance.
• Effective stakeholder management, negotiation and influencing.
• Strategic thinking with ability to translate regulatory requirements into business solutions.