HEAD OF REGULATORY AFFAIRS (OTC DIVISION)Centurion, Gauteng, South Africa
Posted today Full Job DescriptionDrives 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, as applicable. Anticipates, communicates, and manages future regulatory changes and impacts on business success. Communicates to ensure an excellent understanding of Regulatory Affairs. Pays strict attention to detail and accurately monitors and measures progress towards objectives and provides feedback on results whilst maintaining sense of urgency. Strives to maintain a high level of quality. Ensures superior execution by combining the best regulatory practices.
Represents RA at operational meetings such as Group Regulatory, Technical Transfer, QA, Operations, Launch, Artwork/Packaging, Stability, and Research & Development, where proactive input can then enhance operational efficiency. Assists the launch team in order to facilitate a smooth launch process in line with product and dossier compliance; manages all the RA aspects of a launch with respect to product launch plan. Provides information and input to the Group Responsible Pharmacist in order to facilitate appropriate decision-making, ensuring that all SAHPRA requirements are timeously met.
Manages the regulatory and compliance aspects of any project launched into operations including acquisitions and mergers, as well as technical transfer projects. Maintains current knowledge of relevant Acts, Regulations, and Guidelines pertaining to the pharmaceutical industry. Establishes and maintains effective relationships with Regulatory Authorities, internal and external stakeholders. Formulates or implements regulatory affairs systems, policies, and procedures to ensure that regulatory compliance is maintained or enhanced.
Manages activities such as internal audits or regulatory agency inspections and manages an off-site Regulatory Affairs support team. Collaborates and supports the Group Regulatory Affairs function in achieving the company regulatory strategic objectives and goals. Ensures Group Stability Department adheres to applicable regulations and company procedures. Represents Group Stability Department in cross-functional decision-making discussions and Management Escalation and Reporting.
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, commercialization, and dossier maintenance lifecycle.
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