Job Description

Qui sommes-nous ?
Pierre Fabre est le 2eme laboratoire dermo-cosmetique mondial, le 2eme groupe pharmaceutique prive francais et le leader des produits vendus hors prescription dans les pharmacies en France.
Son portefeuille compte plusieurs franchises medicales et marques internationales dont Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avene, Klorane, Ducray, Rene Furterer, A-Derma, Naturactive et Pierre Fabre Oral Care.
Implante depuis toujours en region Occitanie, fabricant plus de 95% de ses produits en France, le groupe emploie pres de 10 000 collaborateurs dans le monde et distribue ses produits dans quelque 130 pays. Pierre Fabre est detenu a 86% par la Fondation Pierre Fabre, une fondation reconnue d'utilite publique, et secondairement par ses collaborateurs a travers un plan d'actionnariat salarie.
En 2021, Ecocert Environnement a evalue la demarche de responsabilite societale et environnementale du Groupe selon la norme ISO 26000 du developpement durable et lui a attribue le niveau Excellence .
Pierre Fabre est reconnu comme l'un des Meilleurs Employeurs du Monde 2021 par Forbes. Notre groupe est classe dans le Top 6 de l'industrie cosmetique et dans le Top 7 de l'industrie pharmaceutique dans le monde. Nous sommes convaincus que notre engagement et notre passion font preserver notre independance et vivre notre raison d'etre.
Votre missionSubmits registration/notification files for Pierre Fabre products to the appropriate local Authorities Ensures maintenance of marketing authorisations/notifications (e.g., renewals, variations, payment of fees as relevant, ...) Prepares and validates packaging information in accordance with the country's legislation in force Validates promotional documents in accordance with the country's legislation in force Organises the archiving and traceability of local files and documents. Assists in any regulatory activity needed to ensure the reimbursement, customs clearance, and the commercialisation according to local legislation (e.g., registration of manufacturing sites,) Manage and improve the exsiting Quality Management System according GxP's and Corporate requirements for all activities dealing with OTC drugs, prescription Drugs, Medical Devices, Cosmetics, biocides and Food supplements Managing annual budget for the regulatory activities

Qui etes-vous ?You have a Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline. A master's degree or PharmD are a plus. Minimum of 3 years' experience in regulatory affairs within the pharmaceutical company in UAE Strong understanding of pharmaceutical regulations and guidelines Familiarity with global regulatory frameworks and compliance standards. Proven track record of successful regulatory submissions and approvals. Proficient in preparing and reviewing regulatory documentation Knowledge of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards. Strong analytical and problem-solving abilities to assess regulatory requirements and compliance. High level of accuracy and attention to detail in documentation and reporting. Excellent written and verbal communication skills to effectively interact with regulatory agencies and cross-functional teams. Strong organizational skills with the ability to manage multiple projects and deadlines efficiently. Ability to work collaboratively across departments to ensure compliance and support product development. Capacity to stay current with changes in regulations and industry standards. Position based in United Arab Emirates
Nous sommes convaincus que la diversite est une source d'epanouissement, d'equilibre social et de complementarite pour nos collaborateurs, nos offres sont donc ouvertes a toutes et tous sans restriction.