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Regulatory Affairs Manager
hace 1 semana
Join Novo Nordisk A/S
We are a leading global healthcare company with a strong legacy in the pharmaceutical industry. Our mission is to drive change to defeat serious chronic diseases and improve patient lives.
Regulatory Affairs Analyst Job Summary
This is an exciting opportunity to work in a dynamic and professional environment where you will be responsible for ensuring regulatory compliance and licence to operate in Argentina. Your primary responsibilities will include managing labelling compliance and updates, monitoring the regulatory environment, and informing impacted areas within the organization.
Key Responsibilities
- Manage the compilation, preparation, and submission of importation letters in compliance with local legislation.
- Evaluate registration files, handle HA queries, coordinate document translations, and submit variations in collaboration with key stakeholders.
- Ensure labelling compliance and updates by developing, reviewing, and updating materials.
- Monitor the regulatory environment and inform impacted areas within the organization.
