The regulatory analyst of Global Regulatory Affairs (GRA) within Health and Biosciences (H&B) will be responsible for completing the administrative work with a focus on supporting the Animal Nutrition & Health manufacturing locations within the United States. The regulatory analyst of GRA is responsible for working with government authorities to request Certificates of Free Sale and Good Manufacturing Certificates. The regulatory analyst’s primary responsibility will be to coordinate document notarizations, apostilles and legalization/authentication requests to support Animal Nutrition and Health product dossiers for countries globally. In addition, this position will have growth opportunities in supporting other regulatory work.
The GRA regulatory analyst specific duties and responsibilities include the following:
- Working with State Authorities to request Certificate of Free Sales by manufacture site and product.
- Working with Global Quality Assurance (QA) to support documentation and obtaining notarizations on documents required to submit for global dossiers.
- Working with US-FDA to request Good Manufacturing Certificates.
- Compiling documentation to work with governmental authorities to obtain apostilles and /or legalization/authentication on documentation packages.
- Utilization of internal ERP and Documentation systems to verify product details, print CoA’s, and pull document templates.
- Organizing documentation for state registrations for Animal Nutrition & Health products in the United States such as feed license applications and renewals, tonnage fee checks, and label submissions with state feed regulators when applicable.
- US FDA food facility registrations for all of H&B manufacturing sites
- Ad hoc administrative support for the regulatory teams such as document organization and purchase orders for invoices
Required qualifications:
- The regulatory analyst position requires at least a bachelor's degree (science background preferred but not required) and no additional experience required. This involves knowledge of handling legal documentation and pursuing notarizations locally.
Preferred qualifications:
- Knowledge on apostille and/or legalization/authentication processes
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