SUMMARY:
The Head of Regulatory Affairs holds ultimate responsibility OTC division's division's regulatory
POSITION INFO:
HEAD OF REGULATORY AFFAIRS (OTC DIVISION) (POS24339)
Midrand
Salary: R 1,700 000 – R 1,800 000
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.
Key Duties:
• 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, 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.
• Represent 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,
• Assist the launch team in order to facilitate smooth launch process in line with product and dossier compliance; to manage all the RA aspects of a launch with respect to product launch plan.
• To give information and input to the Group Responsible Pharmacist in order to facilitate appropriate decision making, ensuring that all SAHPRA requirements are timeously met.
• Manage the regulatory and compliance aspects of any project launched into operations including acquisitions and mergers, as well as technical transfer projects.
• Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
• Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders.
• Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced,
• Manage activities such as internal audits or regulatory agency inspections.
• Manages an off-site Regulatory Affairs support team.
• To collaborate and support the Group Regulatory Affairs function in achieving the company regulatory strategic objectives and goals.
• Ensure Group Stability Department adheres to applicable regulations and company procedures.
• Represent Group Stability Department in cross-functional decision-making discussions and Management Escalation and Reporting.
To apply for this role please forward CV’s to and use Head RA in subject line or POS24339
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