Regulatory Affairs Manager/Senior Manager – CMC, Regulatory Change Management

Thermo Fisher Scientific

. Join the global Regulatory Affairs team in a client-dedicated role supporting commercial medicinal products used in clinical trials, including comparator and auxiliary medicinal products .

Posted 9/22/2026full-timeBasel • SwitzerlandSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in EU/EEA regulatory requirements and CMC documentation, with a strong focus on regulatory change assessments and stakeholder coordination. Proven ability to manage complex regulatory activities and deliverables while ensuring compliance with quality and organizational standards.

Highest-signal resume keywords

EU/EEA Regulatory RequirementsCMC Regulatory DocumentationRegulatory Change AssessmentsClient and Stakeholder ManagementPharmaceutical Manufacturing Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Change AssessmentsCMC Authoring and ReviewClinical Trial Regulatory RequirementsRegulatory IntelligenceSummary of Changes DocumentationRegulatory Impact AnalysisGMP DocumentationSimplified IMPDsClinical Labels ManagementChange-Control Activities

Soft Skills

Analytical SkillsOrganizational SkillsProactive ApproachAttention to DetailChange-Management Skills

Tools & Technologies

Microsoft WordMicrosoft ExcelRegulatory TrackersDocumentation Systems

Industry Keywords

Regulatory AffairsClinical TrialsPharmaceutical SciencesCommercial Medicinal ProductsQuality AssuranceLabellingClinical Supplies

About the role

Key responsibilities & impact

Join the global Regulatory Affairs team in a client-dedicated role supporting commercial medicinal products used in clinical trials, including comparator and auxiliary medicinal products
Perform EU/EEA regulatory assessments of changes, applying applicable legislation, EU Clinical Trials Regulation requirements and regulatory guidance
Assess the impact of CMC, manufacturing, supply and labelling changes on clinical trial documentation and determine appropriate regulatory actions
Prepare and maintain Summary of Changes documentation
Manage product-specific changes impacting sIMPDs, SmPCs and clinical labels
Manage non-product-specific changes impacting manufacturing/release site lists, manufacturing licences and GMP certificates
Review and compare revised SmPCs, clinical labels, manufacturing licences, GMP certificates and related documents
Provide CMC regulatory expertise and support targeted authoring, updating or expert review of sIMPD and other CMC documentation
Coordinate regulatory change-control activities, including planning, stakeholder coordination, action follow-up and maintenance of trackers and systems
Provide regulatory intelligence and practical interpretation of EU/EEA requirements
Collaborate with Regulatory Affairs, CMC, Labelling, Quality Assurance and Clinical Supplies teams
Identify issues, propose pragmatic solutions and ensure activities progress within agreed timelines
Support development and continuous improvement of processes, templates, trackers, decision frameworks and ways of working
Ensure activities and deliverables meet applicable regulatory, quality and organizational requirements

Requirements

What you’ll need

Bachelor's degree or equivalent in a relevant scientific discipline; Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences or related disciplines preferred
8+ years of directly relevant Regulatory Affairs experience, with a strong CMC background
Strong experience with EU/EEA clinical trial regulatory requirements and CMC regulatory documentation
Practical experience performing regulatory change assessments, including assessing the impact of CMC, manufacturing, supply or labelling changes
Experience determining whether changes require substantial or non-substantial modification under applicable EU clinical trial requirements
Experience supporting EU Clinical Trials Regulation submissions
Strong CMC authoring and review expertise, including experience with simplified IMPDs or comparable CMC documentation
Experience with pharmaceutical manufacturing, commercial medicinal products, clinical supplies and/or quality documentation preferred
Experience working directly with clients and coordinating activities across multiple functions and stakeholders preferred
Equivalent combinations of education, training and directly related experience may also be considered
Strong knowledge of EU/EEA clinical trial and CMC regulatory requirements
Ability to interpret regulatory requirements and translate them into clear, practical and defensible regulatory assessments
Strong analytical skills and ability to compare complex documentation and identify regulatory impact
Excellent organizational, planning and change-management skills, with the ability to manage multiple activities and dependencies concurrently
Strong process-oriented mindset, with the ability to bring structure to evolving activities and define effective ways of working
Excellent client and stakeholder management skills, including patience, resilience and professionalism
Proactive approach with the ability to work independently, exercise sound judgement and drive activities to completion
Excellent written and spoken English and strong attention to detail
Strong Microsoft Word and Excel skills, including document review, formatting and version comparison
Ability to work effectively across Regulatory Affairs, CMC, Quality, Labelling, Clinical Supplies and other functions
Comfortable working in a changing and evolving environment

Benefits

Comp & perks

Remote/home-based working may be available from an eligible European location
Ability to attend approximately monthly onsite meetings in the Basel, Switzerland area
Occasional additional travel may be required