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Head of Worldwide Regulatory Affairs
il y a 1 mois
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Gif-sur-Yvette, Île-de-France Servier Temps pleinMain Focus and Challenges:The Regulatory Policy and Intelligence Lead is a new position within World Regulatory Affairs (WRA) in 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...
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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...
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Regulatory Affairs Manager
il y a 3 semaines
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...
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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. This role reports to the Head, Regulatory Policy and Intelligence and is responsible for leading the WRA Regulatory Policy and Intelligence activities.Key Responsibilities:Provide insights and advocate for positions on...
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Regulatory Manager, EAME Regulatory Affairs
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Head of Worldwide Regulatory Policy
il y a 1 mois
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...
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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...
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Regulatory Affairs Specialist
il y a 2 semaines
Neuilly-sur-Seine, Île-de-France International Flavors & Fragrances Temps pleinAbout the RoleWe are seeking a highly skilled Regulatory Manager to join our Scent Regulatory Affairs team at International Flavors & Fragrances. As a key member of our European creative center, you will be responsible for ensuring regulatory compliance and conformity to customer requirements for scent products, including fragrances.Key...
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Gif-sur-Yvette, Île-de-France Servier Temps pleinMain Focus and Challenges:The Regulatory Policy and Intelligence Lead is a key position within Servier's Worldwide Regulatory Affairs team.The incumbent will lead the development and implementation of regulatory policies and strategies to ensure compliance with global regulatory requirements.The Regulatory Policy and Intelligence Lead will be responsible for...
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Gif-sur-Yvette, Île-de-France Servier Temps pleinJoin Our Team as a Regulatory Policy and Intelligence LeadServier, a global pharmaceutical company, is seeking a highly skilled Regulatory Policy and Intelligence Lead to join our Worldwide Regulatory Affairs team. As a key member of our team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with evolving regulatory...
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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...
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Regulatory Policy and Intelligence Lead, Worldwide Regulatory Affairs
il y a 2 semaines
Gif-sur-Yvette, Île-de-France Servier Temps pleinJoin Our Team as a Regulatory Policy and Intelligence LeadServier, a global pharmaceutical company, is seeking a highly skilled Regulatory Policy and Intelligence Lead to join our Worldwide Regulatory Affairs team. As a key member of our team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global...
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Gif-sur-Yvette, Île-de-France Servier Temps pleinJoin Our Team as a Regulatory Policy and Intelligence LeadServier, a global pharmaceutical company, is seeking a highly skilled Regulatory Policy and Intelligence Lead to join our Worldwide Regulatory Affairs team. As a key member of our team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global...
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Regulatory Policy and Intelligence Lead, Worldwide Regulatory Affairs
il y a 2 semaines
Gif-sur-Yvette, Île-de-France Servier Temps pleinJoin Our Team as a Regulatory Policy and Intelligence LeadServier, a global pharmaceutical company, is seeking a highly skilled Regulatory Policy and Intelligence Lead to join our Worldwide Regulatory Affairs team. As a key member of our team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global...
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Regulatory Policy and Intelligence Lead, Worldwide Regulatory Affairs
il y a 2 semaines
Gif-sur-Yvette, Île-de-France Servier Temps pleinJoin Our Team as a Regulatory Policy and Intelligence LeadServier, a global pharmaceutical company, is seeking a highly skilled Regulatory Policy and Intelligence Lead to join our Worldwide Regulatory Affairs team. As a key member of our team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global...
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Global Regulatory Affairs Policy Lead
il y a 1 mois
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...
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Regulatory Affairs Associate Manager
il y a 1 mois
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Global Regulatory Affairs Policy Lead
il y a 1 mois
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...
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Regulatory Liaison Counsel
il y a 2 semaines
Ivry-sur-Seine, Île-de-France Sovos Compliance Temps pleinAbout the RoleSovos Compliance is seeking a highly skilled Regulatory Liaison Counsel to join our team. As a key member of our Regulatory Analysis and Design Department, you will play a critical role in supporting and growing our global ISV ecosystem and revenue stream.Key ResponsibilitiesBridge the gap between Sovos' regulatory expertise and our strategic...
Head Of Regulatory and Quality Affairs
Il y a 3 mois
- Lead and oversee all regulatory and quality activities for the company’s products and services
- Ensure the company’s compliance with national and international regulations applicable to medical devices
- Develop and implement a robust quality management system compliant with ISO standards, other medical device ISO standards and good manufacturing practices
- Implement and supervise an effective risk management process
- Manage regulatory submission processes, obtaining authorizations, and product certification with relevant authorities
- Supervise internal and external audits related to quality and regulatory compliance
- Train and raise awareness among staff about regulatory requirements and quality practices
- Represent the company to regulatory bodies and professional associations
- Advanced degree in engineering, life sciences, or a related field
- Minimum of 5 years of experience in a regulatory and quality role for medical devices
- Excellent knowledge of regulations applicable to in vitro-diagnostics and medical devices (FDA, CE, etc.)
- Proficiency in ISO , ISO , IEC , HITRUST (including SOC2, NIST, ISO standards), and good manufacturing practices
- Proven experience in implementing and managing quality management systems
- In depth familiarity with the risk management process according to ISO
- Strong project management and problem-solving skills
- Hands on mentality
- Excellent written and verbal communication skills in French and English
- Knowledge of the in vitro diagnostics field and analysis device technologies
- Experience in managing regulatory and quality teams
- Ability to work in a dynamic environment and meeting tight timelines
- Strong organizational skills and attention to detail
- Analytical and synthesis skills
- Entrepreneurship
- Experience in Diabetes a plus but not mandatory