Regulatory Specialist

Há 3 dias


São Paulo, São Paulo, Brasil Fortrea Tempo inteiro R$60.000 - R$120.000 por ano

Regulatory Affairs Specialist – Global Submissions & Quality Documentation
Join Fortrea's dynamic global team supporting pharmaceutical product development and lifecycle management. In this role, you'll be responsible for preparing, reviewing, and managing regulatory and quality documentation for submissions to health authorities across the US, EU, and other global markets.

Key Responsibilities

  • 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

What You Bring

  • Bachelor's or advanced degree in Pharmacy, Engineering, Packaging, or related field.
  • Previous experience in Regulatory Affairs, Quality Assurance, Packaging, or related disciplines.
  • Experience in in cosmetics/personal care/skin care/OTC portfolios
  • Fluent English
  • Excellent communication, organization, and problem-solving skills.

Learn more about our EEO & Accommodations request here.


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