Regulatory Quality Manager

Company Description

As a world market leader in crop protection, we help farmers to counter these threats and ensure enough safe, nutritious, affordable food for all – while minimizing the use of land and other agricultural inputs. Syngenta Crop Protection keeps plants safe from planting to harvesting. From the moment a seed is planted through to harvest, crops need to be protected from weeds, insects and diseases as well as droughts and floods, heat and cold. Syngenta Crop Protection is headquartered in Switzerland.

Job Description

Purpose

• Drive compliance with internal global and country specific regulatory requirements and manage regulatory operations effectively.

• Pro-actively manage GHS classification and relevant labeling requirements.

• Effectively and efficiently manage the regulatory Quality Management System (QMS) with a thorough understanding of industry regulations.

• Develop, implement, and maintain standardized procedures and policies to ensure regulatory compliance.

Accountabilities

• Manage the regulatory Quality Management System (QMS) activities related to product registration, submissions, approvals and regulatory compliance of the Regulatory Affairs Team for South Africa BA.

- Key Performance Areas for the management of the regulatory Quality Management System:
1. Regulatory Compliance: Ensure adherence to current regulations of the Regulatory Affairs department by implementing and managing a meticulously structured Quality Management System (QMS), that guarantees alignment of all processes with both national and international standards and regulations.
2. Standardization of Processes: Standardizing processes to ensure consistent submissions of regulatory documentation. Establish uniform procedures and protocols, streamlining the preparation and submission of documents to regulatory authorities to minimize errors and to accelerate the approval process.
3. Change Control: Facilitate and effectively manage changes within the regulatory QMS and ensure that the company remains current with the latest regulatory developments and adapts its processes in line with them.
4. Documentation Management: Streamline the creation, review, approval, and secure storage of regulatory documents to ensure traceability and to meet regulatory compliance requirements.
5. Internal and External Audits: Conduct both internal and external audits to assess the QMS's compliance and efficacy. Identify areas that need enhancement and verify that procedures align with established standards.
6. Risk Management: Ensure that the QMS comprehensively integrates risk management which allows for accurate and efficient identification, evaluation, and mitigation of risks linked to the submission of regulatory documents and adherence to compliance standards.

- Key Activities for the management of regulatory Quality Management System:
1. Coordinate and implement SOPs (Standard Operating Procedures) to streamline regulatory processes (end-to-end) and improve operational efficiency.
2. Implement and maintain regulatory tracking systems and databases to ensure timely reporting and documentation of regulatory activities.
3. Manage the document control process for SOPs, including version control, distribution, and archival and maintain a comprehensive library of SOPs.
4. Monitor regulatory changes, trends and industry best practices related to SOPs; assess and implement necessary updates.
5. Review and revise existing SOPs as necessary to incorporate updates in regulations or process improvements.
6. Monitor and analyze SOP effectiveness and compliance through audits and performance metrics; recommend improvements as needed.
7. Ensure compliance with regulatory requirements and guidelines by maintaining up-to-date knowledge of regulations and industry standards.
8. Coordinate SOP-related activities during regulatory authority inspections and audits; provide documentation and support as needed.
9. Serve as the primary contact for SOP-related enquiries, providing guidance and support to internal stakeholders.
10. Collaborate with cross-functional teams (such as R&D, Marketing, Supply Chain, etc.) to gather input and ensure SOPs reflect current practices and regulatory expectations.
11. Ensure SOPs are accessible and effectively communicated throughout the department and/or organization.
12. Implement SOP training programs to ensure understanding and adherence to SOPs across the department and/or organization.

• GHS SDS (Safety Data Sheets) authoring and maintenance, product hazard communication and chemical compliance with regulatory requirements and industry best practices.
1. Ensure compliance with GHS classification and labeling requirements for hazardous chemicals and products.
2. Interpret and apply global GHS regulations (such as OSHA HazCom, UN Purple book, etc.) to ensure accurate chemical classification and labeling.
3. Collaborate with internal stakeholders (such as CPD, Supply Chain, Marketing and Global Product Safety) to gather necessary data for GHS classification and product defense.
4. Review and approve product labeling to ensure compliance with GHS requirements.
5. Monitor regulatory updates and changes related to GHS and chemical hazard communication and assess the impact on products and operations.
6. Serve as the primary point of contact for GHS-related enquiries from regulatory agencies, customers, and internal stakeholders.
7. Support regulatory submissions by providing accurate and compliant GHS-related documentation.
8. Monitor regulatory changes and updates related to GHS and other applicable regulations from government agencies, including but not limited to, Department of Employment and Labour, Department of Health, Department of Forestry, Fisheries and Environment, Department of Agriculture, Land Reform and Rural Development, etc.
9. Undertake administration of Poison Centre notifications.
10. Responsible to maintain an up-to-date and accurate GHS SDS repository of all formulation components as well as the commercial products.
11. Responsible for substance monitoring and to support business impact studies.
12. Responsible for GHS safety and hazard content on all labels, i.e. for both new and existing commercial products.

• Support ad hoc requests relating to the regulatory function and initiatives based on company need, seasonal workload and company financial necessity.

• Be actively involved in all regulatory EDER (Early Detection, Early Resolution) activities and provide early warning to business on regulatory trends, decision, and impact within the remit of the function.

Qualifications

Experience required for the job

• Experience in data management, project management, and continuous improvement.

• Minimum 5 years of experience in regulatory affairs, with a focus on regulatory operations and GHS classification and labeling.

• In-depth knowledge of GHS classification and labeling requirements for hazardous substances.

• Experience in developing, implementing, and maintaining SOPs within a regulated environment.

• Excellent communication skills and ability to collaborate effectively with cross-functional teams.

• Detail-oriented with a commitment to accuracy and compliance in SOP management.

• Strong knowledge of regulatory requirements (Department of Employment and Labour, Department of Health, Department of Forestry, Fisheries and Environment, Department of Agriculture, Land Reform and Rural Development) and GLP/ISO quality management systems (QMS).

• Proactive problem-solving skills and ability to work independently.

• Risk awareness and a sense of responsibility.

Critical knowledge and education required for the job

• Bachelor's degree in chemistry, chemical engineering, toxicology, or a related scientific discipline.

• In-depth knowledge of Global GHS regulations (OSHA HazCom etc.) and requirements.

• UNITAR GHS Course.

• Good general understanding of business management processes, data management procedures, accounting, and IT systems.

• Competent in VEEVA Document Management System & reporting as required.

• Competent in MS Office applications including Excel, PowerPoint, Access, SmartSheet.

• Good analytical skills and a systematic approach to problem solving combined with good attention to detail.

• Working Knowledge of Project Management methodologies.

Additional Information
Advert Closing 1 April 2025