Regulatory Strategy Lead for Global Clinical Trials

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

Résumé du poste

Thermo Fisher Scientific is seeking a Regulatory Affairs Manager to provide regulatory intelligence and leadership across product development from preclinical stages through registration. You will own regulatory decision-making and guide the cross-functional team to meet program goals.

As the Regulatory Affairs Lead, you will drive global regulatory strategies, ensure timely submissions to authorities and ethics committees, and collaborate with Clinical Operations to align regulatory and

Qualifications

• Bachelor’s degree or equivalent.
• Typically 9+ years of relevant experience.
• Excellent written and verbal English communication.
• Advanced knowledge of global regulatory requirements, including ICH guidelines.

Responsabilités

• Own regulatory decision-making for assigned trials and programs, ensuring alignment with strategy.
• Translate strategy into a trial-level regulatory plan with timelines and deliverables.
• Lead the development and execution of global regulatory strategies and submissions to authorities.
• Drive cross-functional alignment and timely execution of regulatory plans across teams.
• Provide regulatory intelligence and strategic guidance to internal and external stakeholders.

Connaissances

Regulatory strategy

Decision making

Cross-functional leadership

Stakeholder management

Analytical skills

Formation

Bachelor’s degree or equivalent

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

Thermo Fisher Scientific is seeking a Regulatory Affairs Manager to provide regulatory intelligence and leadership across product development from preclinical stages through registration. You will own regulatory decision-making and guide the cross-functional team to meet program goals.

As the Regulatory Affairs Lead, you will drive global regulatory strategies, ensure timely submissions to authorities and ethics committees, and collaborate with Clinical Operations to align regulatory and