Senior Regulatory Affairs & Trial Transparency Liaison, EMEA

ThermoFisher Scientific

France

À distance

EUR 70 000 - 90 000

Plein temps

Il y a 5 jours
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Résumé du poste

Thermo Fisher Scientific seeks a Senior Regulatory Affairs Specialist to drive regulatory intelligence and guidance across preclinical to registration, ensuring deliverables meet local, regional, and ICH requirements while coordinating with clients and internal teams.

You will lead trial transparency activities (CTIS protocol registration, results posting, redaction) and support IDT-level transparency tasks, including anonymization of post‑marketing documents.

Qualifications

  • Bachelor's degree or equivalent in a related field.
  • Minimum 5+ years of experience in regulatory affairs or clinical trials.
  • Experience in transparency activities (protocol registration, CTIS redaction, ClinicalTrials.gov) is a plus.

Responsabilités

  • Manage global disclosure and CTIS deliverables per policy.

Connaissances

English communication
Editorial/proofreading
Interpersonal skills
Project coordination
Budgeting/forecasting
Microsoft Word
Microsoft Excel
PowerPoint
Independent judgment

Formation

Bachelor's degree

Outils

Adobe Acrobat Pro

Description du poste

Thermo Fisher Scientific seeks a Senior Regulatory Affairs Specialist to drive regulatory intelligence and guidance across preclinical to registration, ensuring deliverables meet local, regional, and ICH requirements while coordinating with clients and internal teams.

You will lead trial transparency activities (CTIS protocol registration, results posting, redaction) and support IDT-level transparency tasks, including anonymization of post‑marketing documents.

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