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Regulatory Affairs Specialist
2 months ago
BioPhase Solutions is seeking a highly skilled Regulatory Affairs Associate to join our team. As a key member of our cross-functional team, you will play a critical role in ensuring the commercialization of food, food supplements, dietetic products, energy drinks, and personal care products in the regions of responsibility.
Key Responsibilities- Product Lifecycle Management: Effectively interact and communicate with regional counterparts, manufacturers, and other departments on a daily basis to ensure seamless product lifecycle management.
- Formula Review and Approval: Assist with the review of new preliminary and concept formulas to determine ingredient acceptability and appropriate product classification for corporate initiatives and launches.
- Data Request and Preparation: Request and prepare supporting technical and non-technical data from manufacturers, technical library, and various departmental sources to facilitate product registration and approval.
- Product Setup and Release: Assist with the creation of new SKUs, setup of the Bill of Materials, and completion of the product release to ensure timely market entry.
- Regulatory Compliance: Confirm formula and label acceptability, as well as the receipt of necessary licenses, prior to approving the product to the 'Production' lifecycle.
- Database Management: Initiate and drive changes for items (raw materials, formulas, printed components, SKUs) through the database system to ensure accurate and up-to-date product information.
- Reporting and Data Validation: Prepare reports of all varieties through the database system and assist with the validation of data for use in all reports and queries.
- Regulatory Updates: Stay up-to-date with general and product-specific regulatory developments in projects of responsibility to ensure compliance and market competitiveness.
- Education: Bachelor's degree in a life sciences field.
- Experience: 1+ years of experience working in the food/beverage or personal care industry.
