Thermo Fisher Scientific·3 days ago
3 days ago
Regulatory Affairs Manager/Senior Manager – CMC & Regulatory Change Management - FSP
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What you'll do
- Support EU/EEA regulatory assessments for commercial medicinal products used in clinical trials
- Manage CMC, labelling, and regulatory intelligence activities
- Execute change-control processes
- Coordinate cross-functional activities
- Prepare Summary of Changes documentation
What they're looking for
- Experience in EU/EEA regulatory assessments for commercial medicinal products
- Expertise in CMC (Chemistry, Manufacturing, and Controls)
- Experience with labelling and regulatory intelligence
- Proficiency in change-control processes
- Ability to coordinate cross-functional activities
- Experience preparing Summary of Changes documentation
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Step into the role of Regulatory Affairs Manager/Senior Manager – CMC & Regulatory Change Management - FSP, supporting EU/EEA regulatory assessments for commercial medicinal products used in clinical trials. You will combine CMC, labelling, regulatory intelligence and change-control expertise while coordinating cross-functional activities and preparing Summary of Changes documentation.
Skills
- regulatory affairs
- cmc
- eu/eea regulations
- clinical trial regulation
- regulatory assessment
- change control
- labelling review
- summary of changes
- simpd
- smpc
- gmp certificates
- manufacturing licences
- regulatory intelligence
- english
- stakeholder coordination
- cross-functional collaboration
- document review
- version comparison
- microsoft word
- microsoft excel
- process improvement
- project coordination
- analytical skills
- organisational skills
Company
Thermo Fisher Scientific
Milan, Switzerland
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