Regulatory Affairs Intern

hace 3 meses

Lima, Perú Organon A tiempo completo

Apoyo administrativo al área de Asuntos Regulatorios y Farmacovigilancia, así como soporte continuo a Dirección Técnica, encargándose de procesos específicos regulatorios y la actualización de plataformas tanto externas (DIGEMID), como internas, para asegurar el mantenimiento de los registros sanitarios de la compañía.

Modalidad híbrida (2/3 días en la oficina).

**Responsabilidades Primarias**

El rol y actividad principal será apoyar procesos específicos en el área luego de un plan de capacitación como:

- Organización del expediente físico y digital (manejo y archivo de documentos legales).
- Soporte operativo y administrativo (seguimiento de trámites y pagos a la Autoridad Sanitaria).
- Solicitud de Buenas Prácticas de Manufactura (BPM) y Certificado de Producto Farmacéutico (CPP) con el fin de mantener la base de datos actualizada.
- Solicitud de traducciones para los procesos regulatorios.
- Solicitud de flujos de artes en la plataforma definida y actualización de la base de artes interna.
- Verificar actualización de los Insertos y Fichas Técnicas en las plataformas internas designadas.
- Verificar que todas las resoluciones emitidas por la Autoridad Sanitaria estén cargadas en la carpeta de cada producto.
- Apoyar en la elaboración de dossiers de baja complejidad.

**Educación mínima requerida**

Químico Farmacéutico

**Experencia y habilidades requeridas**
- Conocimientos básicos de la normativa vigente para productos farmacéuticos y dispositivos médicos
- Conocimientos en gestión documental
- Interés por áreas de apoyo administrativo
- Inglés a nível intermedio
- Manejo de office a nível intermedio y/o avanzado
- Trabajo en equipo
- Flexibilidad y adaptación al cambio
- Comunicación efectiva
- Pensamiento analítico
- Compromiso

**Secondary Job Description**

**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

**Search Firm Representatives Please Read Carefully**

**Annualized Salary Range**

**Annualized Salary Range (Global)**

**Annualized Salary Range (Canada)**

**Please Note: Pay ranges are specific to local market and therefore vary from country to country.**

**Employee Status**:
Intern/Co-op (Fixed Term)

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites**

**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R529057

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