Regulatory Affairs Strategist

2 weeks ago

Midrand, Gauteng, South Africa Emporium Human Capital Full time
Job Summary

As a Regulatory Affairs Strategist at Emporium Human Capital, you will be responsible for driving the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives. You will adopt a risk-based assessment for all regulatory submissions and formulate regulatory risk mitigation strategies, as applicable. You will anticipate, communicate and manage future regulatory changes and impacts on business success. You will communicate to ensure an excellent understanding of Regulatory Affairs. You will pay strict attention to detail and accurately monitor and measure progress towards objectives and provide feedback on results whilst maintaining sense of urgency. You will strive to maintain a high level of quality. You will ensure superior execution by combining the best regulatory practices. You will 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. You will assist the launch team in order to facilitate smooth launch process in line with product and dossier compliance. You will manage all the RA aspects of a launch with respect to product and dossier compliance. You will give information and input to the Group Responsible Pharmacist in order to facilitate appropriate decision making, ensuring that all SAHPRA requirements are timeously met. You will manage the regulatory and compliance aspects of any project launched into operations including acquisitions and mergers, as well as technical transfer projects. You will maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry. You will establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders. You will formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced. You will manage activities such as internal audits or regulatory agency inspections. You will manage an off-site Regulatory Affairs support team. You will collaborate and support the Group Regulatory Affairs function in achieving the company regulatory strategic objectives and goals. You will ensure Group Stability Department adheres to applicable regulations and company procedures. You will represent Group Stability Department in cross-functional decision-making discussions and Management Escalation and Reporting.

Key Responsibilities

• Drive the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.
• Adopt a risk-based assessment for all regulatory submissions and formulate regulatory risk mitigation strategies, as applicable.
• Anticipate, communicate and manage future regulatory changes and impacts on business success.
• Communicate to ensure an excellent understanding of Regulatory Affairs.
• Pay strict attention to detail and accurately monitor and measure progress towards objectives and provide feedback on results whilst maintaining sense of urgency.
• Strive to maintain a high level of quality.
• Ensure 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.
• Assist the launch team in order to facilitate smooth launch process in line with product and dossier compliance.
• Manage all the RA aspects of a launch with respect to product and dossier compliance.
• 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.
• Manage an off-site Regulatory Affairs support team.
• 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.

Requirements

• B. Pharm Degree
• Registration with South African Pharmacy Council
• A minimum of 8 years of pharmaceutical regulatory experience
• A minimum of 5 years in people or team management
• Demonstrated experience across the product development, commercialisation and dossier maintenance lifecycle

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