Regulatory Affairs Specialist
hace 2 semanas
About the Role
">Novo Nordisk A/S is seeking a highly skilled Regulatory Affairs Coordinator to join our team in GBS Mexico City.
The successful candidate will be responsible for extending support on compiling, submitting and approving Country Specific Submissions files for responsible countries.
They will also support affiliates in reviewing labelling materials and promotional materials if required, as well as updating local requirements based on regulatory agencies' guidance and input from affiliates/distributors.
A key aspect of this role will be managing working relationships with key stakeholders.
About You
We are looking for a candidate who can demonstrate the following qualifications:
- 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, which is a vibrant hub with a dynamic and collaborative atmosphere.
Our office is dedicated to supporting our global operations and ensuring compliance with regulatory standards.
Join us and contribute to our mission of driving change and improving patient lives.
Benefits
This is an exciting opportunity to pioneer and build an agile unit offering vital business support to the Americas.
You will have the chance to make a significant impact on millions of people living with chronic diseases like diabetes and obesity.
Salary Range
We estimate the salary for this role to be around $80,000 - $120,000 per annum, depending on experience.
Location
This position is based in Mexico City, Mexico.
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