Regulatory Affairs Specialist

hace 1 semana


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

Position Overview


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



About the Role


As a Regulatory Affairs Coordinator at Novo Nordisk A/S, your main responsibilities will include:



  • Providing support on the compiling, submission, and approval of Country Specific Submissions files for responsible countries.
  • Supporting affiliates in reviewing labeling materials and promotional materials if required.
  • Supporting affiliates in updating local requirements based on regulatory agency 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.
  • A minimum of 5 years of work experience within relevant Regulatory Affairs qualifications.
  • Fluency in written and spoken English.
  • Excellent knowledge of pharmaceutical regulatory overview: regulatory guidelines & landscape, regulatory IT systems & tools.


Benefits and Salary


The estimated annual salary for this role is approximately $65,000 USD, depending on location and experience. Our comprehensive benefits package includes health insurance, retirement savings plan, and paid time off.



About Us


Novo Nordisk A/S is a leading global healthcare company with a strong commitment to innovation and patient care. Our GBS team in Mexico City is a dynamic hub with a collaborative atmosphere, dedicated to supporting our global operations and ensuring compliance with regulatory standards.



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