Global Regulatory Affairs Lead - Clinical Trials (CTA)

ThermoFisher Scientific; Roma; Ibrido; EUR 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to join our global Regulatory Affairs team. You will lead regulatory strategies for Phase 1–4 trials, coordinate global submissions and interact with sponsors and clients to ensure compliant deliverables.

Based in Rome, this full-time role offers a chance to impact trials worldwide and collaborate across functions, with emphasis on quality, timelines and scientific excellence.

Competenze

• Bachelor's or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification.
• 8+ years experience in regulatory affairs or related field.
• Knowledge of global clinical trials landscape and regulatory requirements.

Mansioni

• Lead global regulatory strategies for Phase 1–4 clinical trials.
• Coordinate regulatory submissions (CTA) and liaise with sponsors.
• Provide regulatory guidance and liaise with internal/external clients.
• Participate in client/regulatory agency meetings and ensure deliverables.
• Contribute to quality improvement and business development efforts.

Conoscenze

CTA submissions

Sponsor interaction

Regulatory documents review

Literature review

Project leadership

Meetings coordination

Bid defense meetings

Formazione

Bachelor's or higher

8+ years experience

Clinical trials landscape

Strumenti

Microsoft Word

Excel

PowerPoint

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Principal Regulatory Affairs Specialist to join our global Regulatory Affairs team. You will lead regulatory strategies for Phase 1–4 trials, coordinate global submissions and interact with sponsors and clients to ensure compliant deliverables.

Based in Rome, this full-time role offers a chance to impact trials worldwide and collaborate across functions, with emphasis on quality, timelines and scientific excellence.