Regulatory Affairs Manager

Thermo Fisher Scientific

. Own regulatory decision-making for assigned clinical trials and programs .

Posted 10/30/2026full-timeRemote • GermanySeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory decision-making and strategy execution for clinical trials, ensuring compliance with global and regional regulatory requirements. Possesses strong leadership and stakeholder management skills to drive cross-functional teams towards achieving regulatory objectives.

Highest-signal resume keywords

Regulatory Decision-MakingCross-Functional LeadershipRegulatory Strategy ExecutionICH Guidelines ExpertiseProject Budgeting and Forecasting

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory ComplianceClinical Trial AuthorizationIntegrated Protocol DesignsMedical TerminologyStatistical ConceptsAnalytical SkillsProblem-Solving SkillsAttention to DetailNegotiation SkillsConflict Resolution

Soft Skills

Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsTime-Management SkillsIndependent Judgment

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

Regulatory IntelligenceClinical OperationsRegulatory AuthoritiesEthics CommitteesSOPsWPDsLifecycle Management

About the role

Key responsibilities & impact

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

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
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

Benefits

Comp & perks

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