Regulatory affairs specialist

Qui sommes-nous ?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 hereVotre missionWe are Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics to support consumers and patients at every stage of their care journey. Our portfolio includes several medical franchises and international brands such as Eau Thermale Avène, Ducray, A-Derma, Klorane, René Furterer, and Pierre Fabre Oral Care.By joining us, you become part of a meaningful company where the human dimension is essential. You become a participant in the “We Care Movement,” a movement that values excellence and innovation within passionate teams. Together, we push the boundaries of science to unite health and beauty for the benefit of all — because every time we care for a single person, we make the whole world better.Your Mission:Ensure regulatory compliance and manage registrations, variations, and launches for pharmaceutical and dermo-cosmetic products across Mexico and Central America (Dominican Republic, Honduras, and Guatemala).Key Responsibilities:Prepare regulatory dossiers for new registrations, variations, and renewals of medicinal products.Manage advertising and promotional materials for pharmaceutical and dermo-cosmetic products.Follow up and implement packaging changes for medicines and cosmetics.Interact with regulatory authorities (COFEPRIS and Central American agencies).Collaborate cross-functionally with Marketing, Supply Chain, Quality, and Medical teams.Scope:Mexico, Dominican Republic, Honduras, and GuatemalaRequirementsEducationQFB (Pharmaceutical Chemist Biologist) or related degree.ExperienceMinimum 3 years in Regulatory Affairs.Mandatory experience in pharmaceutical and dermo-cosmetic industry.Knowledge of Central American and Mexican regulatory frameworks.Autonomous professional with solid decision-making skills.Technical KnowledgeCOFEPRIS regulationsMaquila notificationsInternal corrections managementAdvertising regulatory complianceWhat We OfferBase salaryAnnual bonus equivalent to one month of salarySuperior benefits packageHybrid work modelAbout UsPresent in 120 countries with a team of over 10,000 employees, we are proud to create a scientific and human impact, today and tomorrow.If caring is at the heart of your values, join Pierre Fabre Laboratories and become a key player in the “We Care Movement.”Diversity & InclusionAt Pierre Fabre Laboratories, we believe that our greatest asset is our people.We are committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law.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.Qui êtes-vous ?Nous sommes convaincus que la diversité est une source d’épanouissement, d’équilibre social et de complémentarité pour nos collaborateurs, nos offres sont donc ouvertes à toutes et tous sans restriction. #J-18808-Ljbffr