Head Of Regulatory Affairs (Otc Division)

Head Of Regulatory Affairs (Otc Division)

• Drives the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives. • Adopts a risk-based assessment for all regulatory submissions and formulates regulatory risk mitigation strategies. Purpose: The Head of Regulatory Affairs holds ultimate responsibility for the OTC division's regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business. The Head of Regulatory Affairs will additionally be responsible for oversight of the Group Stability Department. To ensure legal compliance with the relevant Health Regulatory Authorities (Country Specific where applicable),





Medicines and Related Substances Control Act 101 of 1965, as amended, and South African Pharmacy Act (Act 53 of 1974), and other relevant regulations. The incumbent will serve on the OTC Divisional Leadership team and will therefore be required to act with agility and entrepreneurial flair in driving the financial and compliance objectives of the division. Requirements: • Qualifications: B. Pharm Degree Registration with South African Pharmacy Council. • A minimum of 8 years of pharmaceutical regulatory experience is an absolute prerequisite. • A minimum of 5 years in people or team management is required. • This role requires a high degree of networking and collaboration both within and outside the organisation. • Demonstrated experience across the product development, commercialisation, and dossier maintenance lifecycle.
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▶️ Head Of Regulatory Affairs (Otc Division)
🖊️ Emporium Human Capital
📍 Johannesburg