Work Schedule Standard (Mon-Fri)
Environmental Conditions Office
Job Description Join our global Regulatory Affairs team in a client-dedicated role supporting commercial medicinal products used in clinical trials, including comparator and auxiliary medicinal products.
This highly client-facing position combines
EU/EEA regulatory assessment, CMC and labelling expertise, regulatory change control, Summary of Changes preparation, regulatory intelligence and cross-functional coordination
.
Strong CMC expertise is essential; however, the primary focus is broader than CMC authoring. The role will assess proposed changes, determine regulatory impact, coordinate implementation activities and support the development of effective processes and ways of working.
What You’ll Do
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, including substantiality assessments where applicable.
Prepare and maintain
Summary of Changes (SoC)
documentation.
Manage:
Product-specific changes
impacting sIMPDs, SmPCs and clinical labels.
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 to identify and assess relevant changes.
Provide CMC regulatory expertise and support targeted authoring, updating or expert review of
sIMPD and other CMC documentation when required
.
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 in response to client and cross-functional questions.
Work closely with Regulatory Affairs, CMC, Labelling, Quality Assurance and Clinical Supplies teams to identify regulatory implications, dependencies and required actions.
Proactively identify issues, propose pragmatic solutions and ensure activities progress within agreed timelines.
Support the 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.
Education and Experience Requirements
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.
Knowledge, Skills and Abilities
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
.
Working Conditions
Remote/home-based working may be available from an eligible European location.
Regular client interaction, including participation in
weekly client meetings
, is preferred.
Ability to attend
approximately monthly onsite meetings in the Basel, Switzerland area
is expected.
Occasional additional travel may be required.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Regulatory Affairs Manager/Senior Manager – CMC & Regulatory Change Management - FSP Arbeitgeber: ThermoFisher Scientific
Thermo Fisher Scientific ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in der Pharma- und Biotech-Branche eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf persönliche und berufliche Weiterentwicklung sowie einer Kultur der Zusammenarbeit und Innovation, haben Sie die Möglichkeit, bedeutende Beziehungen zu Kunden aufzubauen und an vorderster Front der wissenschaftlichen Fortschritte zu arbeiten. Darüber hinaus profitieren Sie von flexiblen Arbeitsmodellen und einem internationalen Netzwerk, das Ihre Karrierechancen erheblich erweitert.
