Regulatory Affairs Manager

🕒 il y a 2 jours

🇩🇪 Allemagne – Télétravail

⏰ Temps Plein

🟠 Senior

🔴 Expert

🚔 Conformité

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Thermo Fisher Scientific

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10 000+ employés

🧬 Biotechnologie

💊 Pharmaceutique

🏥 Santé

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific est le leader mondial au service de la science. Sa mission est de permettre à ses clients de rendre le monde plus sain, plus propre et plus sûr. L’entreprise propose un vaste portefeuille d’instruments de laboratoire, de technologies analytiques, de solutions de diagnostic, de consommables, de logiciels et de services destinés à la recherche en sciences de la vie, aux analyses, au diagnostic clinique ainsi qu’au développement et à la fabrication de thérapies. Ses activités et ses offres, telles qu’elles sont présentées sur son site et dans ses communications, comprennent notamment des solutions d’imagerie avancée et des microscopes électroniques, des systèmes de chromatographie et de spectrométrie de masse, des tests génétiques et cliniques, l’automatisation des laboratoires et des outils d’IA, ainsi que des services de bioproduction et de développement et fabrication sous contrat (CDMO). Parmi ses marques figurent Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon et PPD. Thermo Fisher annonce un chiffre d’affaires annuel supérieur à 45 milliards de dollars et met en avant sa responsabilité sociétale, ainsi que ses programmes environnementaux et en faveur des communautés, en complément de ses produits et services scientifiques.

Description

• Own regulatory decision-making for assigned clinical trials and programs • Translate indication-level regulatory strategy into actionable trial-level regulatory strategies and execution plans • Provide strategic regulatory intelligence, guidance, and technical expertise to internal and external stakeholders • Monitor legislation, regulatory requirements, guidelines, and emerging regulatory developments • Serve as a regulatory subject-matter expert across global, regional, and country-specific requirements • Drive cross-functional clinical trial teams to execute regulatory strategies and achieve study and program objectives • Partner with Clinical Operations and other functions to integrate regulatory requirements, dependencies, risks, and timelines into operational plans • Establish regulatory priorities and accountabilities across clinical trial teams • Lead discussions through regulatory challenges and ensure decisions are documented, communicated, and implemented • Escalate significant regulatory risks and strategic issues while owning follow-through and resolution • Participate in launch meetings, project reviews, governance discussions, and project team meetings • Lead global regulatory strategies and prepare submissions to Regulatory Authorities and Ethics Committees • Provide senior review and strategic advice for regional regulatory submissions • Ensure regulatory deliverables are accurate, consistent, compliant, and timely • Ensure compliance with organizational and regulatory SOPs, WPDs, policies, and procedures • Ensure quality performance across assigned and managed projects • Manage project budgets and forecasting activities • Identify out-of-scope activities and support contract modifications • Maintain effective client interfaces and support timely regulatory decisions • Collaborate with Business Development on pricing and new-business opportunities, client presentations, and proposals • Provide matrix/project leadership, coaching, training, and guidance to junior team members

🎯 Exigences

• Bachelor’s degree or equivalent relevant formal academic/vocational qualification • Typically 9+ years of relevant experience • Equivalent combination of appropriate education, training, and directly related experience may be considered • Excellent written and verbal English communication skills, plus local-language capability where applicable • Ability to make and own regulatory decisions • Strong cross-functional leadership and influencing skills in a matrix environment • Strong operational mindset and ability to translate regulatory strategy into executable plans • Ability to identify regulatory and operational risks, evaluate options, recommend actions, and drive resolution • Experience with Platform Protocols and Integrated Protocol Designs highly desirable • Exceptional interpersonal and stakeholder-management skills • Excellent negotiation and conflict-resolution skills • Ability to work independently and exercise sound judgment • Excellent understanding of global, regional, and national regulatory requirements and procedures for clinical trial authorization, licensing, registration, and lifecycle management • Expert knowledge of ICH guidelines and other applicable global regulatory standards • Advanced expertise in one or more regulatory specialty areas, such as clinical, preclinical, CMC, publishing, or related disciplines • Strong understanding of medical terminology, statistical concepts, and relevant scientific and regulatory guidelines • Excellent analytical, investigative, decision-making, and problem-solving skills • Strong organizational, planning, and time-management capabilities • Excellent attention to detail, quality, editorial review, and proofreading skills • Excellent understanding of project budgeting and forecasting • Advanced proficiency with Microsoft Word, Excel, and PowerPoint • Ability to learn and adopt new technologies

🏖️ Avantages

• Fully remote work mode • Standard Monday–Friday work schedule • Preferential treatment for severely disabled applicants with the same aptitude • Opportunity for occasional domestic and international travel

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