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Regulatory Operations Assistant II
Translate and manage global raw material and packaging specifications for regulatory compliance
São Paulo, São Paulo, Brazil
Junior
1 month ago
Fortrea
Provides clinical research and drug development services, supporting biopharmaceutical companies from early-phase trials through post-approval studies.
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Job Title
Science/chemistry graduates who have worked in regulatory affairs
Translate/create/revise raw material, chemical and packaging specifications using client global specification systems as required
Translate/create and manage global change controls for these revisions to the raw material and packaging specifications
Coordinate and interact with external stakeholders like Suppliers and Distributors in local language and get responses
Coordinate and interact with various departments like Procurement, Analytical, Technical Assurance and External manufacturers/sites in local language to understand the change, impact assessment, implementation strategy and required documentation governing the change.
About Fortrea
Provides clinical research and drug development services, supporting biopharmaceutical companies from early-phase trials through post-approval studies.