Hybrid Regulatory Affairs Coordinator Regulatory Affairs Coordinator
Staff Domain · Randburg, Gauteng, South Africa (Remote) · nan, · Hybrid
About the job
Key Responsibilities:
- The Regulatory Affairs Coordinator will be responsible for performing a wide variety of tasks to ensure our products comply with our customers’ global compliance needs. This position will be responsible for requesting/collecting documents from vendors and other sources, and at times having additional testing completed to support use of our products in cosmetic, food and other applications, and will involve working collaboratively with company senior management and key business partners. He/she will support new and existing products, process improvements, and global market compliance as appropriate.
- This position will be responsible for responding to internal and external document requests, tracking timing and progress with vendors, submitting and confirming completion.
- Regulatory Affairs Coordinator is responsible for supporting and implementing the required processes, protocols and programs necessary to support chemical-compliant and robust regulatory practices throughout the company.
- In this position you will be reporting to the Plant Manager. You will work with, and convey information to, all departments within the company, including Senior Management, Sales, Customer Service, Purchasing, and
- Operations.
- Minimum BA or BS degree; chemical documentation and Quality Control familiarity; well-organized with ability to create, modify and maintain document management systems.
- 5 - 10 years of experience within Chemical or related industry, as well as regulatory role.
- Strong knowledge of cGMPs; writing internal documents including SOPs
- Create basic product documents such as SDS after confirming data, especially for products obtained outside USA.
- Hands-on working knowledge of FDA product requirements, experience with FDA inspection.
- Work collaboratively with cross-functional project teams to complete regulatory-related assignments for both new and existing products. Clearly articulate requirements to colleagues.
- Provide regulatory guidance and training as appropriate, ensuring compliance with all regulatory requirements.
- Persist and follow through to resolve document and related customer order problems; understand and determine cause of problem, expedite correction, tenaciously follow up to ensure positive resolution.
- Review documents, product claims and labelling to ensure risk-based regulatory compliance for new and existing products.
- Able to define problems, collect data, establish facts, and draw valid conclusions in any situation, with an excellent attention to written detail, and precise communication skills.
- Experience with Microsoft (Outlook, Excel, Word, Power Point), SharePoint and Access-type systems.
- HMO Coverage
- LIfe Insurance
- Provident Fund
