Job Description

Job Purpose

To provide strategic and operational scientific and clinical leadership to all the Companys internal and external stakeholders.

Required Learning

MBBCH/MBChB Current Registration with the Health Professions Council of South Africa (HPCSA). Post-graduate qualification in Business Science/Management Advancement Programme (MAP)/(MBA) preferred. Minimum of 10 years of experience in the pharmaceutical industry, particularly in the areas of Medical Affairs, Pharmacovigilance, Regulatory and Quality Assurance.

Key Job Outputs

• Provide leadership in Regulatory Affairs and The Companys Regulatory Compliance across all Business Units.
• Ensure that The Companys Responsible Pharmacists comply with all Regulatory requirements for The Company as per the Medicines Act 101 of 1965 and the Pharmacy Act.
• Ensure due diligence on all Regulatory submissions to South African Health Products Regulatory Authority (SAHPRA), resulting in seamless product registrations.
• Ensure all product marketing and advertising is within legal and compliance parameters as dictated by the Code of Marketing Practice in South Africa and other relevant legislation.
• Conduct analysis of industry and legislative requirements, government discussion papers and the formation of opinion on possible impact on The Company.
• Advise the business and make recommendations to mitigate risk or adverse impact of changes in the regulatory framework.
• Provide leadership to the Research and Development (R&D) team in implementing The Companys R&D Goals.
• Partner with the Business Units to enable strategic innovation for sustainability of the respective Business Units.
• Provide leadership to the Medical Affairs function, ensuring optimal delivery in areas of Pharmacovigilance (PV) and Internal and External Stakeholder Relationships:
• Provide leadership to the Group Quality Assurance (GQA) function aligned to current Good Manufacturing Practices (cGMP), the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and Health Authority Guidelines including SAHPRA and rest of Africa Health Authorities
• Stakeholder engagement and Management
• Act as an advisor to key stakeholders within the business, providing clinical guidance and direction in terms of medical affairs.
• Develop professional relationships and collaborate with healthcare professionals, societies and institutions across South Africa to drive cost effective and evidence-based treatments for patients.
• Drive budgeting process for the department within the timelines and framework provided by Group Finance.
• People and strategic leadership

Metamorphosis Integrated Solutions