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Director Regulatory Affairs, China, Hong Kong, Japan
il y a 2 heures
Director Regulatory Affairs, China, Hong Kong, Japan (H/F) 1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Date de parution: 2 oct. 2025 Ville: GIF-SUR-YVETTE Pays/Région: FR Type de contrat: CDI N° offre: 9252 Nous sommes un groupe pharmaceutique à dimension humaine, international et indépendant, gouverné par une Fondation. Notre modèle, singulier, fait notre fierté mais, surtout, nous permet de servir pleinement notre vocation : « engagés pour le progrès thérapeutique au bénéfice des patients ». Aujourd’hui leader mondial en cardiologie, nous avons choisi de devenir un acteur focalisé et innovant en oncologie d’ici 2030, en ciblant des cancers difficiles à traiter et en y consacrant plus de 70 % de notre budget R&D. Un défi que nous poursuivons en parallèle du développement de notre activité générique pour un accès à des soins de qualité pour tous, et à moindre coût. Nous ? 21 900 passionnés de plus de 50 nationalités, portés par un esprit d’entreprenariat. Chaque jour nous avançons avec et pour les patients, avec et pour nos équipes, portés par l’envie de prendre soin, d’oser, de nous développer, de nous engager pour être utiles à celles et ceux qui en ont besoin. Venez vivre et contribuez à faire vivre notre engagement #MovedByYou https://servier.com/groupe/ www.servier.com Mission : Accountable for the elaboration of the regional regulatory strategy and registration processes in Countries under his/her responsibility by respecting the defined schedules and by assisting his/her staff. Propose and implement all required actions for the maintenance of quality standards in regulatory affairs activities, by continuous oversight on regulatory requirements. Lead, manage, develop and motivate the Regulatory Team (RRL), to include annual performance appraisals and objective setting. Ensure the implementation and development of skills, knowledge (e.g. country regulation, SOP e-learning…) and tools to enable members from the Department to achieve their objectives. Activities & Responsibilities : Regional requirements in development plan: Accountable for regional regulatory strategy inputs (e.g. regional specific guidelines, need of ethnic sensitivity data, …). Ensure that RRL from her/his team well define and explain the regional regulatory requirements to the GRT (e.g. clinical data requirements, Regulatory Authority consultation needs & timing). Regulatory Authorities (RA) consultations: Support the RRL for the consolidation and validation of the regional requirements, to advise the GRL with national requirements and adapt the reference Briefing Book or adapted documentation. Support RRL for Leading the preparation of the meeting with Regulatory Authorities (coordinate organization, rehearsals) and participate to the meeting if needed. Registration file procedure, commitments and LCM: Accountable for Marketing Authorization granting and lifecycle maintenance Support her/his team for the preparation of answers to Regulatory Authorities’ questions. Ensure her/his team provide comprehensive explanation of the Regulatory Authorities’ question/position to relevant stakeholders. Ensure the submission of the validated regulatory and scientific documentation to Regulatory Authorities in accordance with the regulatory requirements Follow-up of the regulatory commitments in the concerned country. Ensure her/his team maintain awareness of regulatory focused intelligence, including regulatory precedents for the concerned countries. Lead and support activities to ensure an efficient implementation of the regulatory strategy for existing assets and commercial products. Internal communication: Facilitate interactions between local and Headquarter teams Ensure a good collaboration with internal stakeholders and attend meetings to support the team when necessary Ensure that her/his team support and accompany the LRA (e.g. sharing information, routine zone meetings, …). Ensure that relevant information is shared among the RRL in the team (teams meeting,…) Qualifications: Knowledge of national legislation and regulations related to medicinal products concerning the dedicated region Awareness of the regulatory procedures in the region for scientific Advice/ Authority consultation , registration, post approval changes, extensions and renewals Knowledge of and experience in regional regulatory environment in relevant product area and development stage Knowledge of drug development Regulatory submissions experience Working with policies and procedures Experience interacting with Regulatory Authorities Communication skills – both oral and written Ability to understand and communicate scientific/clinical information Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across concerned regional countries and international borders Profile : Bachelor’s degree or equivalent experience with M/S, Pharm D, PhD/MD. Master’s degree and at least 5 years of experience in regulatory or pharmaceutical drug development. Nous sommes engagés pour l’égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l’expérience qu’à l’envie de s’engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer. #J-18808-Ljbffr
