Analista de Asuntos Regulatorios

Job description

Who we are ?

The Pierre Fabre Group is unique in France: 2nd Dermo-Cosmetics laboratory in the world and 2nd private French Pharmaceutical group. Our group is 86% owned by the Pierre Fabre Foundation, recognized as being of public utility by the French government and which is dedicated to improving access to quality care and medicines in the least favored countries. This original shareholders structure ensures the independence of the company.

Our mission: "Every time we take care of one person, we make the world a better place.

"To achieve this, we cooperate with healthcare professionals, our trusted partners around the world, relesentlessly drawing inspiration from nature and plants, and placing pharmaceutical ethics at the very heart of our operations.

We are established in 45 countries and in more than 130 countries thanks to distribution agreements. Opening up to the international market has always been at the heart of our strategy.

Our head office is located in a region that is close to our hearts: Occitanie, in particular the Tarn department, where the group was founded and has been established since its inception.

Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant on the basis of race, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expressionand identuty, disability, or any other kind of discrimination. You can find more about us here

Your mission

Funciones :

· 
Participar en la definición de las estrategias regulatorias considerando las prioridades, viabilidad y las dimensiones del área comercial, mediante la evaluación de los riesgos regulatorios y la propuesta de soluciones específicas a los proyectos.

· 
Ejecutar todas las actividades relativas al puesto en cumplimiento a lo establecido en las políticas corporativas y en los procedimientos normalizados de operación aplicables.

· 
Revisar, analizar y gestionar la información para recopilar un expediente robusto acorde a la regulación sanitaria vigente, anticipando posibles prevenciones y asegurando la emisión de la aprobación por parte de la autoridad sanitaria.

· 
Asegurar la correcta comunicación entre las diferentes áreas de Pierre Fabre para la oportuna implementación de las acciones derivadas de las aprobaciones obtenidas.

· 
Revisar y aprobar los materiales promocionales, materiales de empaque y etiquetas legales de producto de acuerdo a la regulación vigente.

· 
Identificar y prever riesgos importantes en el sometimiento, aprobación e implementación de las autorizaciones por COFEPRIS.

Requisitos:

· 
Lic. Quimica Farmaceutica o afin

· 
Minimo 3 años Experiencia en regulación Local de medicamentos

· 
Experiencia en regulación Local en productos cosmeticos

· 
Inglés Avanzado

· 
Conocimiento Formato CTD y guías ICH

Who you are ?

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.