Regulatory Affairs & Trial Transparency Lead (EMEA)

ThermoFisher Scientific; Italia; Remoto; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific in Italy is seeking a Senior Regulatory Affairs Specialist to lead global disclosure and regulatory submissions, ensuring compliance with ICH and regional requirements across product development from preclinical to registration.

You will coordinate CTIS/ClinicalTrials.gov registrations, manage redactions, advise clients, and collaborate with internal teams to drive efficient, compliant deliverables in a fast-paced environment.

Competenze

• Bachelor's degree or equivalent in a relevant field.
• 5+ years of related experience.
• 3+ years in clinical trials and transparency roles preferred.
• Understanding of global regulatory guidelines (ICH, etc.).

Mansioni

• Coordinate global disclosure and transparency deliverables per policy.
• Register trials in ClinicalTrials.gov and CTIS, and manage result postings.
• Coordinate redactions of CTIS documents identifying confidential information.
• Provide regulatory strategy and technical advice to clients.
• Lead project-specific transparency processes and collaborate across departments.
• Support business development and budgeting/forecasting.

Conoscenze

English communication

Interpersonal skills

MS Office (Word/Excel/PowerPoint)

Analytical skills

Project management

Budgeting & forecasting

Formazione

Bachelor's degree

Strumenti

Microsoft Word

Excel

PowerPoint

Adobe Acrobat Pro

Descrizione del lavoro

Thermo Fisher Scientific in Italy is seeking a Senior Regulatory Affairs Specialist to lead global disclosure and regulatory submissions, ensuring compliance with ICH and regional requirements across product development from preclinical to registration.

You will coordinate CTIS/ClinicalTrials.gov registrations, manage redactions, advise clients, and collaborate with internal teams to drive efficient, compliant deliverables in a fast-paced environment.