Remote EU Regulatory Affairs Lead – CMC & Change Control

ThermoFisher Scientific; Lavamünd; Hybrid; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Remote work option

Zusammenfassung

Thermo Fisher Scientific in Austria is hiring for a client-dedicated Regulatory Affairs expert supporting medicinal products used in clinical trials, including comparator and auxiliary products. The role combines EU/EEA regulatory assessment, CMC and labeling expertise, regulatory change control and SoC preparation.

You’ll work cross-functionally with CMC, Labelling, QA and Clinical Supplies teams to identify regulatory implications, coordinate change-control activities and provide regulatory

Qualifikationen

• 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.

Aufgaben

• 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.
• 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 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.

Kenntnisse

Regulatory affairs

CMC expertise

Regulatory assessments

Change control

Regulatory intelligence

Cross-functional coordination

Client-facing

English language

Ausbildung

Bachelor's degree in a relevant scientific discipline

Tools

Microsoft Word

Microsoft Excel

Jobbeschreibung

Thermo Fisher Scientific in Austria is hiring for a client-dedicated Regulatory Affairs expert supporting medicinal products used in clinical trials, including comparator and auxiliary products. The role combines EU/EEA regulatory assessment, CMC and labeling expertise, regulatory change control and SoC preparation.

You’ll work cross-functionally with CMC, Labelling, QA and Clinical Supplies teams to identify regulatory implications, coordinate change-control activities and provide regulatory