Emplois actuels liés à Labelling Regulatory affairs Manager - GifsurYvette - Servier
-
Head of Worldwide Regulatory Affairs
il y a 4 semaines
Gif-sur-Yvette, Île-de-France Servier Temps pleinGlobal Regulatory Affairs Policy LeadOversee Regulatory Policy and Intelligence initiatives within the Worldwide Regulatory Affairs (WRA) division at Servier.Deliver insights on international regulatory challenges and developments to research and development partners.Act as Servier's representative at Regulatory Conferences and Symposia.Establish an internal...
-
Global Regulatory Affairs Policy Lead
il y a 4 semaines
Gif-sur-Yvette, Île-de-France Servier Temps pleinGlobal Regulatory Affairs Policy LeadOversee Regulatory Policy and Intelligence initiatives within the Worldwide Regulatory Affairs (WRA) division at Servier.Deliver insights on international regulatory challenges and developments to Research and Development collaborators.Act as Servier's representative at various Regulatory Conferences and...
-
Global Regulatory Affairs Policy Lead
il y a 4 semaines
Gif-sur-Yvette, Île-de-France Servier Temps pleinGlobal Regulatory Affairs Policy Lead Servier is a global pharmaceutical organization headquartered in Suresnes, operating under a non-profit Foundation (FIRS, Fondation Internationale de Recherche Servier), dedicated to advancing therapeutic innovations that address patient needs. With a robust international footprint, our research and development,...
-
Regulatory Affairs Manager
il y a 1 semaine
Neuilly-sur-Seine, Île-de-France International Flavors & Fragrances Temps pleinJob Title: Regulatory Affairs ManagerJob Summary:We are seeking a highly skilled Regulatory Affairs Manager to join our team at International Flavors & Fragrances. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements for our fragrance products.Key Responsibilities:Develop and...
-
Global Regulatory Affairs Policy Lead
il y a 4 semaines
Gif-sur-Yvette, Île-de-France Servier Temps pleinAbout Servier:Servier is a globally recognized pharmaceutical organization, characterized by its independent and human-centric approach, guided by a Foundation. Our distinctive model empowers us to fulfill our mission of promoting therapeutic advancements for the benefit of patients. As a leading entity in cardiology, we aspire to establish ourselves as a...
-
Regulatory Manager, EAME Regulatory Affairs
Il y a 3 mois
Neuilly-sur-Seine, France International Flavors & Fragrances Temps pleinJob Description Are you passionate about fragrance creation and developing the fragrances of tomorrow? We are now seeking for a motivated and result driven talent to join our Scent Regulatory Affairs team. As a Regulatory Manager , you will be responsible for the regulatory compliance and conformity to customer requirements for scent products,...
-
Gif-sur-Yvette, Île-de-France Servier Temps plein**About Us**Servier is a human-sized, international, and independent pharmaceutical group governed by a Foundation. Our unique model is our pride, but above all, it allows us to fully serve our vocation: 'committed to therapeutic progress for the benefit of patients'. Today, we are a global leader in cardiology, and we have chosen to become a focused and...
-
Gif-sur-Yvette, Île-de-France Servier Temps pleinAbout ServierServier is a leading international pharmaceutical company dedicated to driving therapeutic progress and serving patient needs. With a strong presence in nearly 70 countries, Servier employs over 21,900 people worldwide, including 4,500 in France. The company's mission is to develop innovative treatments that improve patients' lives.Our...
-
Gif-sur-Yvette, France Servier Temps pleinServier is an international pharmaceutical company based in Suresnes governed by a non-profit Foundation (FIRS, Fondation Internationale de Recherche Servier), with the mission to drive therapeutic progress which will serve patient needs. Relying on a solid international presence, R&D, production and subsidiaries’ activities are carried out in nearly 70...
-
EAME Regulatory Affairs Lead
il y a 4 semaines
Neuilly-sur-Seine, Île-de-France International Flavors & Fragrances Temps pleinJob Overview Are you enthusiastic about the art of fragrance development and the regulatory frameworks that support it? We are currently in search of a dedicated and results-oriented professional to become a key member of our Scent Regulatory Affairs division. In the capacity of Regulatory Manager, you will oversee the adherence to regulatory standards and...
-
Regulatory Policy and Intelligence Lead
il y a 2 jours
Gif-sur-Yvette, Île-de-France Servier Temps pleinAbout ServierServier is a global pharmaceutical company dedicated to improving patient lives through innovative therapies. With a strong presence in over 70 countries, we strive to drive therapeutic progress and serve patient needs.Job SummaryWe are seeking a highly skilled Regulatory Policy and Intelligence Lead to join our Worldwide Regulatory Affairs...
-
Regulatory Policy and Intelligence Lead
il y a 2 jours
Gif-sur-Yvette, Île-de-France Servier Temps pleinMain Focus and Challenges:The Regulatory Policy and Intelligence Lead is a key position within World Regulatory Affairs (WRA) at Servier, a global pharmaceutical company. The incumbent will report to the Head, Regulatory Policy and Intelligence and be responsible for leading WRA's Regulatory Policy and Intelligence activities.Key Responsibilities:Provide...
-
Regulatory Policy and Intelligence Lead
il y a 1 jour
Gif-sur-Yvette, Île-de-France Servier Temps pleinAbout ServierServier is a global pharmaceutical company dedicated to improving patient lives through innovative therapies. With a strong presence in over 70 countries, we strive to drive therapeutic progress and serve patient needs.Job SummaryWe are seeking a highly skilled Regulatory Policy and Intelligence Lead to join our Worldwide Regulatory Affairs...
-
Head of Worldwide Regulatory Policy
il y a 4 semaines
Gif-sur-Yvette, Île-de-France Servier Temps pleinAbout Servier:Servier is a mid-sized pharmaceutical organization with a global perspective, operating independently under a Foundation. Our distinctive model empowers us to fulfill our mission of enhancing therapeutic advancements for patient benefit. As a leading entity in cardiology, we aspire to establish ourselves as a pioneering and innovative force in...
-
Regulatory Affairs Associate Manager
il y a 3 semaines
Neuilly-sur-Seine, France International Flavors & Fragrances Temps pleinJob Summary Who we are Our Pharma Solutions Regulatory Team is growing and we are looking for a dedicated and passionate individual to join our team as a Regulatory Affairs Associate Manager to provide regulatory support including registration for our products used in industrial (non - food, non What we offer Working at an international company with an...
-
Food Law Counsel Dairy
Il y a 4 mois
Gif-sur-Yvette, France Danone Temps pleinAbout the job The General Secretary Department is recruiting a Junior Food Law Counsel - Dairy category M/F. The position is based in Gif-Sur-Yvette (91). The Food Law Department drives the legal and regulatory strategy and provides support to GS&C, R&I and CBU (Country Business Unit) teams to ensure regulatory compliance of our innovations and related...
-
Regulatory Policy and Intelligence Lead
il y a 1 jour
Gif-sur-Yvette, Île-de-France Servier Temps pleinMain Focus and Challenges:The Regulatory Policy and Intelligence Lead is a key position within World Regulatory Affairs (WRA) at Servier, responsible for leading the WRA Regulatory Policy and Intelligence activities. The incumbent reports to the Head, Regulatory Policy and Intelligence and is expected to provide leadership to ensure science and risk-based...
-
Cdi - International Regulatory Affairs Manager
Il y a 3 mois
Neuilly-sur-Seine, France Sephora Temps pleinAt Sephora we inspire our customers, empower our teams, and help them become the best versions of themselves. We create an environment where people are valued, and differences are celebrated. Every day, our teams across the world bring to life our purpose: to expand the way the world sees beauty by empowering the ExtraOrdinary in each of us. We are united...
-
Regulatory Compliance Manager
il y a 1 semaine
Is-sur-Tille, Bourgogne-Franche-Comté, France Michael Page Temps pleinAs a key member of the Michael Page team, you will play a crucial role in ensuring the company's products comply with all relevant regulations and standards.Key Responsibilities:Regulatory Affairs: Manage the regulatory affairs function, ensuring compliance with all applicable laws, regulations, and industry standards.Product Compliance: Oversee the...
-
Regulatory Compliance Manager
il y a 2 semaines
Neuilly-sur-Seine, Île-de-France International Flavors & Fragrances Temps pleinJob Overview:We are seeking a highly skilled Regulatory Manager to join our Scent Regulatory Affairs team at International Flavors & Fragrances. In this role, you will be responsible for ensuring regulatory compliance for scent products, working closely with perfumers, account teams, and customers.About the Role:As a Regulatory Manager, you will be based at...
Labelling Regulatory affairs Manager
Il y a 4 mois
Fondé pour servir la santé, Servier est un groupe pharmaceutique international gouverné par une Fondation, qui aspire à avoir un impact sociétal significatif pour les patients et pour un monde durable. Son modèle unique de gouvernance lui permet de servir pleinement sa vocation avec une vision à long terme : être engagé pour le progrès thérapeutique au bénéfice des patients. Les 21 800 collaborateurs qui composent le Groupe sont engagés autour de cette vocation commune, source d’inspiration au quotidien. Leader mondial en cardiologie, Servier a pour ambition de devenir un acteur reconnu, focalisé et innovant en oncologie en ciblant des cancers difficiles à traiter. C’est pourquoi le Groupe consacre plus de 50 % de son budget de R&D au développement de thérapies ciblées et innovantes en oncologie. Les neurosciences et les maladies immuno-inflammatoires constituent un futur relais de croissance. Dans ces domaines, Servier se focalise sur un nombre restreint de pathologies spécifiques dans lesquelles une caractérisation précise des patients permet de proposer une réponse thérapeutique ciblée, grâce à la médecine de précision. Pour favoriser l’accès à des soins de qualité pour tous, et à moindre coût, le Groupe propose également une offre de médicaments génériques couvrant la majorité des pathologies, en s’appuyant sur des marques fortes en France, en Europe de l’Est, au Brésil et au Nigeria. Dans tous ces domaines, le Groupe intègre la voix du patient à chaque étape du cycle de vie du médicament. Servier, dont le siège social est basé en France, s’appuie sur une solide implantation géographique dans plus de 150 pays et a réalisé, en 2021, un chiffre d’affaires de 4,7 milliards d’euros.
Main focus & challenges :
Accountable and responsible for developing and maintening processes for managing all aspects of labelling Be involved since the clinical development phase and all along the lifecycle of the products Define and improve the processes related to the global labelling Organize and manage the labelling teamKey responsibilities :
Develop, maintain and review when applicable, in accordance with regulatory guidelines and available data, the following elements : Target Product Label, Company Core Data Sheet (CCDS) and Company Core Safety Information (CCSI) or equivalent USPI and SmPC or equivalent derivation from CCDS Lead the cross functionnal labelling working groug for an Oncolgy product Responsible for developing and leading the process of review of the labelling materials Develop et maintain the Quality System (SOP, templates, guides) covering the labelling management system and ensure the appropriate training of the key stakeholders Build and manage the labelling managers team and monitor the outsourcing teamProfiles :
Master’s degree or PhD and minimum 5 years of experience in labelling management. Hard Skills / Expertise: Knowledge of global/regional regulatory guidelines and requirements needed regarding core market regions (US, EU) Excellent written and verbal communication skills Pharmaceutical labelling experience Complete fluency in English language Project management experience Leadership skills: Leadership and succesful previous experience of team management Experience of leading and coordinating cross-functionnal teams Soft Skills: Identifies and resolves problems in a proactive manner Ability to multi-task, prioritize and manage multiple projects Ability to liaise with stakeholders using effective means of communication Ability to take informed decisions in a complex environment Good organization skills and ability to manage timelines and project pressureQuel que soit votre domaine d'expertise, votre travail au sein du Groupe Servier contribue à faire avancer le progrès thérapeutique au bénéfice des patients. Vous ferez partie d'équipes reconnues pour leur excellence scientifique et développerez votre plein potentiel dans un environnement professionnel qui vous encourage à vous développer. Des parcours d'intégration sur mesure, des opportunités de mobilité, des formations de qualité, un management responsable, un esprit d'équipe... Tout cela et plus encore dans un lieu de travail axé sur votre bien-être.
Chez Servier, nous sommes engagés dans le progrès thérapeutique au service des besoins des patients. Nous mettons la diversité de nos collaborateurs comme une source de richesse pour l'accomplissement de cette vocation.
