Regulatory Affairs Specialist

hace 2 semanas


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

Position for Novo Nordisk GBS Mexico

We are seeking a highly skilled Regulatory Affairs Coordinator to join our team in GBS Mexico City. The ideal candidate will have experience in managing submissions and approvals, as well as a strong understanding of regulatory guidelines and landscape.

The Role

As a Regulatory Affairs Coordinator, you will be responsible for:

  • Providing support on the compilation, submission, and approval of Country Specific Submissions files for the responsible countries.
  • Reviewing and supporting affiliates in updating local requirements based on regulatory agencies' guidance and input from affiliates/distributors.
  • Managing working relationships with key stakeholders.

Requirements

To be successful in this role, you will need:

  • A graduate or postgraduate degree in pharmacy, science, or a relevant field.
  • At least 5 years of work experience within relevant Regulatory Affairs qualifications.
  • Fluent written and 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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