Regulatory Affairs Manager

🔥 1 minute ago

🌐 Belgium, Italy, +3 more countries – Remote

🇧🇪 Belgium – Remote 🇮🇹 Italy – Remote 🇩🇪 Germany – Remote 🇬🇧 United Kingdom – Remote 🇳🇱 Netherlands – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Provide regulatory affairs expertise, client interface, strategic regulatory intelligence, and guidance supporting product development from preclinical stages through registration and product optimization • Own regulatory decision-making for assigned clinical programs • Drive cross-functional clinical trial teams toward execution of regulatory strategy and achievement of program objectives • Translate indication-level regulatory strategy into actionable trial-level strategies and execution plans • Define regulatory pathways, priorities, deliverables, dependencies, risks, and timelines • Maintain current knowledge of legislation, regulatory requirements, guidelines, and emerging regulatory developments • Serve as regulatory subject-matter expert across global, regional, and country-specific requirements • Integrate regulatory requirements, dependencies, risks, and timelines into study operational plans with Clinical Operations and other functions • Establish regulatory priorities and accountabilities and identify issues affecting deliverables or milestones • Lead cross-functional discussions through regulatory challenges and ensure decisions are documented, communicated, and actioned • 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 preparation of 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 delivered on time • 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 communicate recommendations, risks, and options • Collaborate with Business Development on pricing and new-business opportunities, client presentations, proposals, scopes, and budgets • Provide matrix/project leadership, coaching, training, and guidance to junior team members

🎯 Requirements

• 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 while balancing regulatory requirements, strategic objectives, operational feasibility, risk, and timelines • Strong cross-functional leadership and influencing skills in a matrix environment • Strong operational mindset and ability to translate regulatory strategy into executable plans, milestones, dependencies, and actions • 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

🏖️ Benefits

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

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