Regulatory Affairs Lead — Clinical Trials Strategy

ThermoFisher Scientific; Milano; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Regulatory Affairs Manager to lead regulatory decision-making across assigned clinical programs, translating high-level strategy into concrete execution plans. You will drive collaboration with Clinical Operations and other teams to ensure timely regulatory milestones and compliant submissions while managing risk and dependencies.

Ideal candidates bring extensive regulatory expertise, strong decision-making, and the ability to steer complex programs in a

Competenze

• Bachelor’s degree or equivalent in a relevant field.
• 9+ years of relevant regulatory affairs experience typically required.
• Experience leading regulatory strategy and cross-functional teams.

Mansioni

• Own regulatory decision-making for assigned clinical trials and programs.
• Translate strategy into actionable trial-level plans and timelines.
• Lead global regulatory submissions and ensure compliance with regulatory requirements.
• Drive cross-functional alignment and execution across the clinical trial team.

Conoscenze

Regulatory strategy

Cross-functional leadership

Decision making

Regulatory intelligence

English communication

Formazione

Bachelor’s degree

Strumenti

Microsoft Word

Excel

PowerPoint

Descrizione del lavoro

Thermo Fisher Scientific is seeking a Regulatory Affairs Manager to lead regulatory decision-making across assigned clinical programs, translating high-level strategy into concrete execution plans. You will drive collaboration with Clinical Operations and other teams to ensure timely regulatory milestones and compliant submissions while managing risk and dependencies.

Ideal candidates bring extensive regulatory expertise, strong decision-making, and the ability to steer complex programs in a