Regulatory Affairs Specialist

hace 4 semanas


Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

Position Overview

We are seeking a highly skilled Regulatory Affairs Coordinator to join our team in GBS Mexico City. As a key member of our team, you will be responsible for supporting the compilation, submission, and approval of Country Specific Submissions files for the responsible countries.

Key Responsibilities

  • Provide support on the compilation, submission, and approval of Country Specific Submissions files for the responsible countries.
  • Support affiliates in reviewing labelling materials and promotional materials if required.
  • Support affiliates in updating local requirements based on regulatory agencies guidance and input from affiliates/distributors.
  • Manage working relationships with key stakeholders.

Requirements

  • Graduate/Postgraduate in pharmacy, science, or relevant field.
  • 5+ years of work experience within relevant Regulatory Affairs qualifiers.
  • Fluent in written & spoken English.
  • Excellent knowledge of Pharmaceutical Regulatory overview: Regulatory guidelines & landscape, Regulatory IT systems & tools.

About the Department

You will be part of our GBS team in Mexico City, working in a dynamic and collaborative atmosphere. Our team is dedicated to supporting our global operations and ensuring compliance with regulatory standards. If you are passionate about regulatory affairs and have the necessary skills and experience, we encourage you to apply for this exciting opportunity.



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