EU Regulatory Change Leader - CMC & RA Expert

ThermoFisher Scientific; Italia; À distance; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Thermo Fisher Scientific seeks an experienced Regulatory Affairs professional to support EU/EEA regulatory assessments of changes for clinical trial documentation and related CMC activities. The role focuses on coordinating regulatory change control, SoC preparation and interaction with cross-functional teams.

The candidate will review SmPCs, labels, manufacturing licences and GMP certificates, providing regulatory intelligence and expert review of CMC documentation as needed.

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• 8+ years of directly relevant Regulatory Affairs experience with strong CMC background.
• Strong experience with EU/EEA clinical trial regulatory requirements.
• Practical experience performing regulatory change assessments.
• Experience with EU Clinical Trials Regulation submissions.
• Strong CMC authoring and review skills, including experience with simplified IMPDs or comparable CMC documentation.
• Experience working with clients and coordinating activities across multiple functions.

Responsabilités

• Perform EU/EEA regulatory assessments of changes, applying applicable legislation and guidance.
• Assess the impact of CMC, manufacturing, supply and labelling changes on clinical trial documentation and determine regulatory actions.
• 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, licences and GMP certificates.
• Review revised SmPCs, clinical labels, manufacturing licences and GMP certificates.
• Coordinate regulatory change-control activities and maintain trackers.
• Provide CMC regulatory expertise and support targeted authoring or review of CMC documentation when required.
• Provide regulatory intelligence and interpretation of EU/EEA requirements in response to client questions.
• Work with Regulatory Affairs, CMC, Labelling, Quality Assurance and Clinical Supplies teams to identify regulatory implications.
• Identify issues and propose solutions to keep activities on track.
• Develop and improve processes, templates and decision frameworks.
• Ensure activities meet regulatory, quality and organizational requirements.

Connaissances

EU/EEA regulations

CMC regulatory

Regulatory assessments

Regulatory change control

Documentation review

Client management

Formation

Bachelor's degree in science

Outils

Microsoft Word

Microsoft Excel

Description du poste

Thermo Fisher Scientific seeks an experienced Regulatory Affairs professional to support EU/EEA regulatory assessments of changes for clinical trial documentation and related CMC activities. The role focuses on coordinating regulatory change control, SoC preparation and interaction with cross-functional teams.

The candidate will review SmPCs, labels, manufacturing licences and GMP certificates, providing regulatory intelligence and expert review of CMC documentation as needed.