Regulatory Affairs Specialist

hace 2 semanas


Ciudad de México, Ciudad de México Ortho Clinical Diagnostics A tiempo completo

The Opportunity

At Ortho Clinical Diagnostics, we're united by a shared passion for transforming the power of diagnostics into a healthier future for all. As a world-leading in vitro diagnostics company, we're committed to delivering fast, accurate, and consistent testing solutions that make a real difference in people's lives.

Our culture is built on the principles of happiness, inspiration, and engagement. We believe that our team members are our greatest asset, and we strive to create an environment that fosters growth, innovation, and collaboration.

We're seeking a highly skilled Regulatory Affairs Associate to join our team. In this role, you'll play a critical part in ensuring the success of our regulatory submissions, from preparation to follow-up. Your expertise will be instrumental in coordinating technical and legal documentation, preparing submission dossiers, and supporting quality notifications and CAPAs.

Key Responsibilities

  • Prepare new and renewal submission dossiers by coordinating technical and legal documentation.
  • Prepare technical modification dossiers, including digital copies and legal documentation.
  • Coordinate the conciliation of notifications, quality notifications, and closure of them.
  • Support complaints and notification compilation for Technovigillance reports.
  • Support importation processes by communicating changes, approvals, and label changes.
  • Follow up on submissions in the COFEPRIS system.
  • Update regulatory databases with the latest information.
  • Perform other work-related duties as assigned.

Requirements

  • Major in Pharmacy, Chemistry, or Biochemistry.
  • At least 3 years of experience in quality and/or regulatory affairs.
  • At least 3 years of experience in the pharmaceutical or life science industry in manufacturing/quality and/or regulatory affairs.
  • Advanced knowledge of MS Office.
  • Fluent in English.
  • Traveling 10%.


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