Regulatory Affairs Manager

Thermo Fisher Scientific

. Provide regulatory affairs expertise, client interface, strategic regulatory intelligence, and guidance supporting product development from preclinical stages through registration and product optimization .

Posted 11/6/2026full-timeRemote • Belgium, Italy, Germany, United Kingdom, NetherlandsSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs, including strategic regulatory intelligence and decision-making for clinical programs. Proficient in translating regulatory strategies into actionable plans while ensuring compliance with global and regional requirements.

Highest-signal resume keywords

Regulatory Affairs ExpertiseCross-Functional LeadershipRegulatory Strategy DevelopmentClinical Trial Authorization KnowledgeICH Guidelines Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Decision-MakingRegulatory Pathway DefinitionProject BudgetingOperational Risk EvaluationPlatform Protocols ExperienceIntegrated Protocol DesignsRegulatory Submissions PreparationQuality Performance ManagementAttention to DetailAnalytical Problem-Solving

Soft Skills

Excellent Communication SkillsInterpersonal SkillsNegotiation SkillsConflict Resolution SkillsOrganizational Skills

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

Clinical TrialsRegulatory RequirementsSOPsWPDsLifecycle ManagementMedical TerminologyStatistical ConceptsGlobal Regulatory StandardsStakeholder ManagementProject Management

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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