Global Regulatory Affairs Consultant
il y a 3 jours
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
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Alternance - Global Regulatory Affairs
il y a 7 jours
Les Ulis, France IPSEN Temps plein**Title**: Alternance - Global Regulatory Affairs, Neurosciences M/F **Company**: Ipsen Innovation (SAS) IpsenTraineeSquad Ipsen is pleased to open a **12-month apprenticeship **(alternance) in the Global Regulatory Affairs, Neuroscience team! We are looking for a motivated **Regulatory Affairs student** **to work in our R&D office in **Les Ulis**,...
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Senior Manager, Global Regulatory Affairs
il y a 5 jours
Les Ulis, France Ipsen Innovation (SAS) Temps pleinJob title**:Senior Manager, Global Regulatory Affairs TA** Department: Research & Development, Global Regulatory Affairs (GRA) Line Manager (name, job title): VP/Sr Dir/Dir, Global Regulatory Affairs, Therapeutic Area Location of the role: France, (Les Ulis or Boulogne-Billancourt) **Summary / purpose of the position** - To be accountable for the...
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Alternance - Global Regulatory Affairs Operations
il y a 6 heures
Les Ulis, France Ipsen Innovation (SAS) Temps pleinAs a Regulatory Operation internship, you will play a role in supporting Regulatory operation projects aimed at enhancing regulatory activities by using Regulatory information management system capabilities. You will work closely with our Regulatory, Regulatory operation, System& IT team to contribute to the development and implementation of strategies to...
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Alternance - Regulatory Affairs Rare Diseases (M/F)
il y a 7 jours
Les Ulis, France IPSEN Temps plein**Title**: Alternance - Regulatory Affairs Rare Diseases M/F **Company**: Ipsen Innovation (SAS) IpsenTraineeSquad Ipsen is pleased to open a **12-month apprenticeship **(alternance) in the Global Regulatory Affairs, Rare Disease team! We are looking for a motivated **Regulatory Affairs student** **to work in our R&D office in **Les Ulis**, France. - 12...
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Expert, Cmc Regulatory
il y a 5 jours
Les Ulis, France Ipsen Innovation (SAS) Temps pleinJob Title: Expert CMC Regulatory Division / Function: Global Regulatory Affairs - CMC Regulatory Manager (Name, Job Title): Senior Manager, Director, or Senior Director CMC Regulatory Location: Ipsen location in France / Ireland / UK **Summary / purpose of the position** - Prepare the CMC regulatory strategy for assigned projects under the strategic...
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Director, Regulatory Systems
il y a 2 semaines
Les Ulis, France Ipsen Innovation (SAS) Temps plein**Position** Job Title**:Director, Regulatory Systems Lead** Division / Function: Global Regulatory Affairs - Regulatory Operations Manager (Name, Job Title): Head of RegOps, GRA Location: Boulogne / Les Ulis - France **Summary / purpose of the position** Position Overview: **Main responsibilities / job expectations** **Direct management of the system...
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Senior Director, Policy
il y a 3 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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Alternance - Regulatory Affairs Cmc F/m - From
il y a 6 heures
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...
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Gra Compliance Manager
il y a 7 jours
Les Ulis, France Ipsen Innovation (SAS) Temps plein**As Regulatory Compliance Manager within the GRA Excellence organization and under the Regulatory Compliance Senior Manager**: - Oversee all compliance aspects related to Global Regulatory Affairs activities in accordance with regulatory requirements and IPSEN standards. - Share compliance outcomes with the Global Regulatory Affairs community and relevant...
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SAP Consultant
il y a 3 jours
Les Ulis, France RED Global Temps pleinOverviewConsultant SAP PP – Opportunité FreelanceRED Global est à la recherche d'un Consultant SAP PP expérimenté pour rejoindre un projet de grande envergure. Vous interviendrez au sein d’un environnement international.Informations clésDémarrage : Au plus viteLocalisation : France, avec présence sur site flexibleDurée : Mission longue (durée...
