Regulatory Affairs Analyst
hace 7 días
**Regulatory Affairs Analyst**
**Your task and responsabilities**
- Support to the Regulatory Affairs area in the preparation and submission of dossiers for new registrations, variations, FSC and others.
- Support to Clinical Operations on the submission of clinical research protocols and amendments.
- Responsible for the submission of the advertising promotional materials in DIGIPRIS and in the internal platforms.
- Supports the Regulatory team on administrative tasks such as: submission and collection of approvals in COFEPRIS, notification of approvals to the regulatory team, update of the different databases and of the internal systems ensuring the regulatory compliance of the area, control and reception of different documents, etc.
- Responsible for the management of the regulatory archive.
- Support in the implementation of the digital systems of COFEPRIS.
- Supports to the Pharmacovigilance team on the submission of different documents to the authority.
**Who you are**:
- Work Experience: minimum 2-3 years in the Pharmaceutical Industry. Career such as: Pharmacist, QFB, QFI, QBP, and others.
- Knowledge of Medicines and Medical devices regulation.
- Special Sills: Microsoft Office, DIGIPRIS management, and others.
- English: minimum intermediate level is required
- Assertive communication, Organization, Results oriented, Collaborates across teams, Digital mindset, Manages Complexity.
**Período de aplicación**:
- del 9 al 23 de diciembre
**Código de referencia**:
- 834875
**División**:
- Pharmaceuticals
**Ubicación**:
- Mexico : Ciudad de México : Ciudad de México
**Área funcional**:
- Administración y servicios
**Grado de posición**:
- G
**Tipo de empleo**:
- Permanente
**Tiempo de trabajo**:
- Full Time
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