Global Regulatory Affairs Consultant

il y a 4 jours

Les Ulis, France Real Temps plein

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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