Job Description
Company: Lupin
Location: CMX, MX
Job Description- Gestionar, revisar, y proteger la documentación generada en Investigación y Desarrollo para la integración de expedientes técnicos para medicamentos y dispositivos médicos (nuevos registros y modificaciones).
- Ensure compliance with national and international standards, pharmacopoeias, and guidelines, coordinating with internal and external multidisciplinary areas during development.
- Manage and validate the translation of required technical documentation, ensuring its integrity compared to the original documents.
- Prepare technical justifications and respond to requests from health authorities regarding technical dossiers.
- Verify calculations in formulation documentation, analytical development, validation, and stability studies.
- Assign codes and manage documentation and procedures related to technical dossiers and project administration.
- Define, p...