Chargé d'Affaires Réglementaires H/F (CDD)

Job description

Who we are ?

Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.

Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care. 

Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan. 

In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.

Pierre Fabre is recognized as one of the "World's Best Employers 2021" by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide. 

Your mission

Manage the regulatory activities and guarantee regulatory compliance of products in his scope of responsibility:- Ensure that necessary regulatory requirements and proceedings are respected throughout the life cycle of products- Manage and/or coordinate the constitution of regulatory dossiers and see that content is compliant, ensure that regulatory proceedings relative to application for marketing approval are carried out according to regulations in force - Support the local regulatory affairs department in the implementation of regulatory strategy; coordinate and/or participate in the development of answers to regulatory authorities- Ensure compliance of all promotional material, from packaging items to digital media, where applicable

Who you are ?

Vous êtes Pharmacien ou issu(e) d’une formation supérieure de niveau Bac+5 avec un Master en enregistrement des médicaments en Europe et à l’International, complétée par une expérience de 2 ans ou plus dans les affaires réglementaires LCM.

Vous êtes à l’aise pour vous exprimer dans un anglais professionnel, à l’oral comme à l’écrit.

Vous maîtrisez les outils de bureautique, collaboratifs, et une connaissance des bases de données réglementaires (RIm, Promomats ou eq., Trackwise…).

Au-delà de vos compétences techniques, vous êtes reconnu(e) pour :

·  Votre rigueur
·  Votre capacité d’analyse et de synthèse
·  Votre organisation et votre réactivité
·  Votre esprit collaboratif et votre engagement

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.