Regulatory Affairs Analyst

hace 1 día

Ciudad de México G Pharma A tiempo completo

**REQUIRED CRITERIA**
- Career Degree of **Q.F.B. Titled (mandatory).**:

- Experience**:Minimum 2 years of experience as a Regulatory Affairs Analyst in dosseires assembly for medicines (mandatory).**:

- Knowledge of national health regulation (NOM 059, 177, 072, 073, 220, RIS, etc).
- Gender: Indistinct.
- Language**:Advanced English Level B2 (mandatory). The job interview will be carried on in this language.**

**MAIN DUTIES**
- Review of the technical and legal documentation so as to dossiers assambly for new Generic Medicine Products in order to get the sanitary registrations.
- Management and processing of renewals, modifications and extensions for medicines marketing authorization.
- Modifications to the medicines marketing authorization conditions: technical or administrative according to the needs of the company, updating and / or preparing the labeling projects and IPPS for medicines.
- Maintain a documentation control of each product registered to follow up and comply with the procedures required before the health authority.
- Follow up on internal compliance with health regulations to identify deviations and propose a CAPA plan.
- Collaborates with the Regulatory Affairs team and international regulatory colleagues to provide regulatory support for new products.
- Support in the development of PNO's for Quality and PV departments.
- Attendance and Follow-up to the Pharmacovigilance unit.
- Other documentary and administrative activities.

**WE OFFER**
- Competitive Salary.
- Benefits provided by Law.
- Schedule: Monday to Friday from 8:00 am to 5:00 pm.
- Workplace: Benito Juarez - CDMX.
- Workstation: Fulltime, indefinite period.

Tipo de puesto: Tiempo completo, Por tiempo indeterminado

Salario: Hasta $25,000.00 al mes

Horario:

- Diurno
- Lunes a viernes
- Turno de 8 horas

Prestaciones:

- Horarios flexibles
- Opción a contrato indefinido

Experiência:

- Analista de Asuntos Regulatorios: 2 años (Obligatorio)

Idioma:

- Inglés (Obligatorio)

Licencia/Certificación:

- Química Farmacéutico Biológica (Obligatorio)

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