Emplois actuels liés à Global Regulatory Affairs Consultant - Les Ulis - Real
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Senior Manager Regulatory Affairs
il y a 7 jours
Les Ulis, France elemed Temps pleinSenior Regulatory Affairs Consultant The Company: If you are a QA/RA professional with an interest in innovation and groundbreaking development, we have an incredible role for you. This is a chance to join an established midsize Software as a Medical Device company. Role Responsibilities & Qualifications: Develop and execute regulatory strategies/plans that...
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Manager, Global Regulatory Affairs
il y a 1 semaine
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Develop and implement regulatory strategies for the assigned projects and all its components for a major region or worldwide.**: - **Be responsible for the strategy, and implementation of all regulatory aspects of the assigned projects and all of its components for a major region or worldwide.**: - **Provide regulatory expertise to R&D, Franchise and...
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Senior Regulatory Affairs Specialist
il y a 1 semaine
Issy-les-Moulineaux, France Johnson & Johnson MedTech Temps pleinAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
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Global Regulatory Strategist
il y a 1 semaine
Issy-les-Moulineaux, France Johnson & Johnson MedTech Temps pleinA global medical technology company is seeking a Senior Regulatory Affairs Specialist in Issy-les-Moulineaux, France. The role involves supporting regulatory compliance for Ethicon Endomechanical products, collaborating with cross-functional teams on new EU regulations, and contributing to the creation of Technical Documentation for MDR CE marking. Ideal...
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Senior Director, Policy
il y a 5 jours
Les Ulis, France Nokia Temps pleinSenior Director, Policy & Government Affairs – Nokia Job Description The Senior Director, Policy & Government Affairs will lead Nokia’s U.S. congressional affairs, lobbying strategy, and engagement with federal policymakers and staff. This role will serve as the primary interface between Nokia and the U.S. Congress and relevant committees. The individual...
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Director Regulatory Affairs Rare Diseases
il y a 1 semaine
Les Ulis, France Ipsen Innovation (SAS) Temps plein**SUMMARY OF THE ROLE** - To be accountable for the strategy, tactics and implementation of all regulatory aspects of the assigned programs and all of its components for assigned region or worldwide. - To provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects. - Act as the interface between the...
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Global Labeling Manager
il y a 1 semaine
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** **To develop and maintain Core labelling documents and support USPI/other local product information throughout the product life cycle in accordance with Ipsen Processes for assigned product(s)** **To provide labelling guidance to support product teams and senior management in defining labelling strategy** **To provide...
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Senior Manager, Global Labelling
il y a 1 semaine
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Summary / purpose of the position** **To develop and maintain Core labelling documents and support USPI/other local product information throughout the product life cycle in accordance with Ipsen Processes for assigned product(s)** **To provide labelling guidance to support product teams and senior management in defining labelling strategy** **To provide...
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Project Manager Regulatory Ecosystems
il y a 2 semaines
Les Ulis, France IPSEN Temps plein**Title**: Project Manager Regulatory Ecosystems **Company**: Ipsen Innovation (SAS) In close collaboration with the Regulatory Systems Owner and Regulatory System Support and within the framework to leverage and improve the Regulatory Ecosystems - Manage systems trainings - Participation in tool’s evolution - Oversight manager provider - Manager systems...
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Alternance - Regulatory Affairs Cmc F/m - From
il y a 5 jours
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Regulatory coordination**: - Participate to the CMC regulatory strategy liaising with cross functional teams - Check current regulations to ensure strategy is developed in alignment - Participate to build, review and maintain CMC regulatory documentation for ongoing clinical programs (IMPD/IND) - Participate in the authoring and reviewing phase of...
Global Regulatory Affairs Consultant
il y a 2 heures
Join to apply for the Global Regulatory Affairs Consultant role at RealJoin to apply for the Global Regulatory Affairs Consultant role at RealThis range is provided by Real. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Our client, a leader in the industry, is looking for a Global Regulatory Affairs Consultant to join their team on a contract basis. This role is integral to supporting regulatory initiatives, new registrations outside of the EEA, and regulatory lifecycle management. If you have a passion for navigating the complex world of regulatory compliance, this opportunity is for you.Key ResponsibilitiesCompile and submit regulatory documents according to requirements and timelines.Provide expert regulatory advice to project teams and ensure timely responses to regulatory authority inquiries.Maintain regulatory documentation in compliance with CTD and EU regulation standards.Drive lifecycle management plans, including variation submissions and supporting device registrations.Represent Regulatory Affairs in cross-functional project teams.CTD and CMC Expertise: Proven ability to work with Common Technical Documents and Chemistry, Manufacturing, and Controls data.EU Regulation Knowledge: Strong understanding of MRP/DCP procedures and international regulation frameworks.Scientific Knowledge: Comprehensive knowledge of pharmaceutical sciences.Communication: Excellent verbal and written communication skills in English.Negotiation: Capable of managing regulatory discussions effectively.Technical Proficiency: Skilled in using word processing tools, spreadsheets, databases, and conducting online research.Project Management: Ability to manage multiple projects with strict deadlines.Compliance Awareness: Detect compliance risks and take appropriate actions swiftly.QualificationsBachelor's degree in pharmacy or related scientific discipline.3-5 years of regulatory experience within a pharmaceutical company, CRO, or similar organization (higher degrees such as a PhD are advantageous).Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeTemporaryJob functionJob functionOtherIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Real by 2xGet notified about new Regulatory Affairs Consultant jobs in Île-de-France, France.Regulatory Affairs Senior Specialist (m/f/d)REGULATORY AFFAIRS MANAGER & PHARMACOVIGILANCE SPECIALISTRueil-Malmaison, Île-de-France, France 2 weeks agoCDI - Senior Regulatory Affairs Pharmacy Manager - (H/F)Senior Manager, Global Regulatory AffairsSenior Regulatory Counsel - Licensing & AffairsFreelance / Consultant 1 FTE Local Safety Officer in FranceRESPONSABLE POLE AFFAIRES REGLEMENTAIRESProduct Owner Global Regulatory Affairs (m/f/d)International Scientific Regulatory Affairs SpecialistBoulogne-Billancourt, Île-de-France, France 3 weeks agoBoulogne-Billancourt, Île-de-France, France 3 weeks agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
