{"id":885,"date":"2026-09-11T09:38:46","date_gmt":"2026-09-11T07:38:46","guid":{"rendered":"https:\/\/madeconseil.com\/?post_type=offres&#038;p=885"},"modified":"2026-09-11T09:38:46","modified_gmt":"2026-09-11T07:38:46","slug":"charge-daffaires-reglementaires-h-f","status":"publish","type":"offres","link":"https:\/\/madeconseil.com\/en\/offres\/charge-daffaires-reglementaires-h-f\/","title":{"rendered":"Charg\u00e9 d&rsquo;Affaires R\u00e9glementaires H\/F"},"content":{"rendered":"<div class=\"oxy-container-885-100 oxy-container section-default section-offre\"><h1 class=\"oxy-text-885-101 oxy-text heading-1\">\nCharg\u00e9 d'Affaires R\u00e9glementaires - H\/F\n<\/h1><h2 class=\"oxy-text-885-114 oxy-text text-white offre-texte\">\nBuild a career that matters.\n<\/h2><p class=\"oxy-text-885-102 oxy-text text-white offre-texte translation-block\">At made., we have built a model that allows consultants to commit to demanding projects without sacrificing either their work-life balance or their professional trajectory.<br>We see engineering consulting as a true profession, practiced at the heart of our clients\u2019 projects.<br>We support healthcare industrial players in their most critical quality projects, within demanding regulated environments: pharmaceutical, biotech, medical devices.<br>Above all, we have chosen to break down silos and unlock career paths by putting people back at the center of consulting.<br>Here, you work on projects that matter, within a socially committed framework, with a trajectory designed for the long term.<\/p><h2 class=\"oxy-text-885-107 oxy-text text-white offre-texte\">\nYour role\n<\/h2><p class=\"oxy-text-885-108 oxy-text text-white offre-texte\">\nNous recherchons un(e) Charg\u00e9(e) d'Affaires R\u00e9glementaires pour rejoindre nos \u00e9quipes et intervenir sur un projet strat\u00e9gique li\u00e9 \u00e0 l'extension d'un site de fabrication pharmaceutique.<br><br>Dans un contexte international, vous contribuez \u00e0 la gestion des dossiers IMPD, au suivi des d\u00e9p\u00f4ts r\u00e9glementaires et \u00e0 la veille r\u00e9glementaire sur plusieurs march\u00e9s majeurs, notamment en Europe, aux \u00c9tats-Unis, en Chine et au Japon.<br><br>Votre r\u00f4le :<br><br>En tant que consultant made., vous prenez en charge la coordination et le suivi des activit\u00e9s r\u00e9glementaires n\u00e9cessaires \u00e0 l'avancement du projet.<br><br>Vous assurez la gestion des dossiers pharmaceutiques, suivez les diff\u00e9rentes \u00e9tapes des d\u00e9p\u00f4ts et veillez \u00e0 la prise en compte des exigences r\u00e9glementaires propres aux diff\u00e9rents march\u00e9s concern\u00e9s.<br><br>\u00c0 l'interface avec les diff\u00e9rents contributeurs du projet, vous garantissez la qualit\u00e9, la coh\u00e9rence et la tra\u00e7abilit\u00e9 de la documentation r\u00e9glementaire, ainsi que le respect des \u00e9ch\u00e9ances.<br>\n<\/p><h2 class=\"oxy-text-885-109 oxy-text text-white offre-texte\">\nYour day-to-day<br>\n<\/h2><p class=\"oxy-text-885-110 oxy-text text-white offre-texte\">\nVous serez notamment amen\u00e9(e) \u00e0 :<br><br>contribuer \u00e0 la pr\u00e9paration, \u00e0 la gestion et \u00e0 la mise \u00e0 jour des dossiers IMPD<br>coordonner la collecte des informations et documents n\u00e9cessaires aupr\u00e8s des diff\u00e9rents contributeurs<br>v\u00e9rifier la qualit\u00e9, la coh\u00e9rence et la compl\u00e9tude de la documentation r\u00e9glementaire<br>assurer le suivi des d\u00e9p\u00f4ts et des diff\u00e9rentes \u00e9ch\u00e9ances associ\u00e9es<br>contribuer au suivi r\u00e9glementaire des dossiers sur plusieurs march\u00e9s internationaux<br>prendre en compte les exigences r\u00e9glementaires applicables en Europe, aux \u00c9tats-Unis, en Chine et au Japon<br>r\u00e9aliser une veille r\u00e9glementaire sur les diff\u00e9rentes zones concern\u00e9es<br>analyser les \u00e9volutions r\u00e9glementaires susceptibles d'avoir un impact sur le projet<br>assurer le suivi administratif et documentaire des activit\u00e9s r\u00e9glementaires<br>coordonner les \u00e9changes avec les diff\u00e9rentes parties prenantes internes et externes<br>identifier les informations manquantes et relancer les contributeurs afin de s\u00e9curiser les \u00e9ch\u00e9ances<br>assurer le reporting et la tra\u00e7abilit\u00e9 des actions r\u00e9glementaires\n<\/p><h2 class=\"oxy-text-885-111 oxy-text text-white offre-texte\">\nYour profile\n<\/h2><p class=\"oxy-text-885-112 oxy-text text-white offre-texte\">\nIssu(e) d'une formation Bac +5 scientifique, pharmaceutique, r\u00e9glementaire ou \u00e9quivalent, vous disposez id\u00e9alement d'au moins 3 ans d'exp\u00e9rience professionnelle en Affaires R\u00e9glementaires dans l'industrie pharmaceutique.<br><br>Vous avez une bonne connaissance de la gestion de dossiers pharmaceutiques, id\u00e9alement des IMPD, et \u00eates \u00e0 l'aise avec le suivi des d\u00e9p\u00f4ts et des \u00e9ch\u00e9ances r\u00e9glementaires.<br>Une exp\u00e9rience ou une bonne connaissance des Affaires R\u00e9glementaires internationales sera particuli\u00e8rement appr\u00e9ci\u00e9e, notamment sur plusieurs des march\u00e9s suivants : Europe, \u00c9tats-Unis, Chine et Japon.<br><br>Compte tenu de la dimension internationale du projet, un anglais professionnel courant est imp\u00e9ratif, \u00e0 l'\u00e9crit comme \u00e0 l'oral.<br><br>Nous recherchons avant tout un profil autonome, dynamique et rapidement op\u00e9rationnel, capable de comprendre les enjeux r\u00e9glementaires, de structurer les informations et de faire avancer ses dossiers efficacement.<br><br>Vous \u00eates reconnu(e) pour votre rigueur administrative et documentaire, votre organisation et votre capacit\u00e9 \u00e0 g\u00e9rer plusieurs sujets et \u00e9ch\u00e9ances simultan\u00e9ment.\n<\/p><h2 class=\"oxy-text-885-115 oxy-text text-white offre-texte\">\nWhy join made.?\n<\/h2><p class=\"oxy-text-885-116 oxy-text text-white offre-texte translation-block\">Joining made. means:<br><br>\u2022 practicing consulting as a true profession,<br>\u2022 working on structuring projects, not opportunistic assignments,<br>\u2022 growing through the diversity and complexity of client projects,<br>\u2022 being supported in your development through a simple, direct relationship,<br>\u2022 building a coherent and evolving professional trajectory.<br><br>Want to learn more?<br><br>We take the time to talk.<br>Send us your application in complete confidentiality.<\/p><a class=\"oxy-text-link-885-113 oxy-text-link button-white\" href=\"#nous-contacter\" target=\"_self\">\nAPPLY\n<\/a><\/div>","protected":false},"template":"","class_list":["post-885","offres","type-offres","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Charg\u00e9 d&#039;Affaires R\u00e9glementaires H\/F - Made 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