Labelling Regulatory affairs Manager
il y a 4 semaines
Servier 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 countries around the world and drugs are available in 150 countries. The turnover of the group reaches more than €4.9 billion (2022).
Servier employs more than 21,400 people worldwide, including 4,500 in France.
In March 2023, the Servier R&D Institute opened its doors in the cross-disciplinary innovation hub at Paris-Saclay. The aim of this Servier R&D Institute at Paris-Saclay is to combine the Group’s innovation potential with a powerful ecosystem and a center of scientific excellence. The objective is to develop Research 4.0; the Group looks to the future in order to anticipate the challenges faced by generations in considering health from a global perspective, keeping the patient at the heart of its concerns.
Faced with the climate emergency and environmental degradation Servier's commitment to the planet encourages us to adopt measures to reduce our greenhouse gas emissions and to strengthen our involvement in favor of biodiversity and the preservation of natural resources. We adopt a global and integrated approach throughout the pharmaceutical value chain.
The ambitions for 2025 are as follows:
• Launch one new molecular entity every three years
• Become a key player in oncology
• Reach €6.5 Bn in consolidated revenue
• Increase EBITDA to €1.3 Bn to sustain heavy investment in development
All employees are driven by shared values and guided by a common vision, sharing a passion for entrepreneurship and committed to therapeutic progress to serve patient needs.
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 periodically review, 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 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, Japan) 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 pressureWhatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.
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