SPECIALIST REGULATORY AFFAIRS H/M

Job description

Información general

Referencia

2018-4460

Fecha de publicación

16/04/2018

Branch

Farma

Compañía

PIERRE FABRE FARMA DE MEXICO SA DE CV

Descripción puesto

Perfil del puesto

QRVI (Calidad, Reglamentación, Vigilancias, Información médica) - Responsable de asuntos regulatorios

Título del puesto

SPECIALIST REGULATORY AFFAIRS H/M

Categoría

Ejecutivos

Horario de Trabajo

Tiempo Completo

Misión

Execute in a timely manner the programs of submissions that ensure the approval and maintenance of the sanitary authorizations of the products assigned from the PFM and PFDC portfolio in Mexico in order to provide the company with authorizations for the commercialization of the products, in compliance with what is established in the regulatory framework of the authorities.

Perfil

Degree in areas of health with a focus on pharmaceuticals (QFB, QFI, QBP, IBI)
Language: English (advanced), French (desirable)

Experience: 3 years in regulatory areas within the pharmaceutical industry, practical knowledge in conducting follow-up to the various regulatory procedures.

RESPONSIBILITIES:
Participate in the definition of regulatory strategies, considering the priorities, viability and dimensions of the commercial area through the evaluation of regulatory risks and the proposal of specific solutions to projects.
Execute all activities related to the position, in compliance with the provisions of the corporate policies and standardized processes of the applicable operation.
-Promote a good understanding with the regulatory area of the parent company to ensure the complete and correct collection of the information necessary to obtain sanitary approvals in Mexico.
- Review, analyze and manage the necessary information to create a robust file in accordance with current sanitary regulations, anticipating possible preventions ensuring the issuance of approval by the health authority in Mexico.
- Coordinate the execution of the actions required by the internal clients as suppliers and business partners in the regulatory field for the assigned projects, in order to guarantee the execution of the strategy.
-Review and approve the promotional material and packaging material according to the current regulation.

Fecha límite para aplicación

30/04/2018

Ubicación del puesto

Ubicación del puesto

Americas, México, Distrito Federal/ Área Metropolitana

Lugar de Trabajo

LEGARIA

Criterios del candidato

Nivel mínimo de estudios requerido

Licenciatura

Titulado

3-Titulo Universitario

Especialización

·  Ciencias- Biología
·  Regulatorio y Vigilancia
·  Ciencias- Otros
·  Ciencias- Química

Nivel mínimo de experiencia requerido

3 o más años de experiencia

Idiomas

·  Inglés (3 - Profesional)
·  Francés (2 - Intermedio)