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Regulatory Affairs Specialist

hace 2 meses

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

The Opportunity

At Ortho Clinical Diagnostics, we are a world-leading in vitro diagnostics company with a strong presence in over 130 countries. Our mission is to transform the power of diagnostics into a healthier future for all. We are seeking a highly skilled Regulatory Affairs Associate to join our team.

Key Responsibilities

  • Prepare and submit regulatory documents, including technical and legal documentation, to ensure compliance with regulatory requirements.
  • Coordinate the conciliation of notifications, quality notifications, and closure of them to ensure seamless regulatory operations.
  • Support the importation process by communicating changes, approvals, and label changes to ensure regulatory compliance.
  • Follow up on submissions in the COFEPRIS system to ensure timely and accurate regulatory reporting.
  • Update and maintain regulatory databases to ensure accurate and up-to-date information.
  • Perform other work-related duties as assigned to support the team's goals and objectives.

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 in MS Office.
  • Fluent in English.
  • Traveling 10%.

About Us

We are a company that puts our team members first and prioritizes actions that support happiness, inspiration, and engagement. We strive to build meaningful connections with each other and believe that employee happiness and business success are linked.