Regulatory Affairs Lead - Strategy & Execution

ThermoFisher Scientific; Brussel Hoofdstad; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Thermo Fisher Scientific in Belgium is seeking a Regulatory Affairs Manager to lead strategic regulatory decisions supporting product development from preclinical stages through registration and lifecycle optimization. The role emphasizes an operational mindset, ownership of decisions, and cross-functional leadership.

The incumbent will drive regulatory strategy, coordinate global submissions with regulatory authorities and ethics committees, and partner with Clinical Operations to align

Qualifications

• Bachelor’s degree or equivalent relevant formal academic/vocational qualification.
• Typically 9+ years of relevant experience providing regulatory affairs knowledge and abilities.

Responsabilités

• Own regulatory decision-making for assigned trials and programs, ensuring decisions align with strategy.
• Translate strategy into an actionable trial-level plan with regulatory pathways, priorities and timelines.
• Provide strategic regulatory intelligence, guidance, and technical expertise to internal and external stakeholders.
• Maintain knowledge of applicable legislation and guidelines, translating into operational guidance.
• Serve as regulatory subject-matter expert across global, regional, and country-specific requirements.
• Drive the cross-functional clinical trial team to execute the regulatory strategy and objectives.
• Collaborate with Clinical Operations to integrate regulatory requirements into study plans and budgets.
• Lead development and execution of global regulatory strategies and submissions to authorities and ethics committees.
• Maintain client interfaces, communicating risks and options to support timely regulatory decisions.

Connaissances

Regulatory strategy

Cross-functional leadership

Decision making

Project management

Formation

Bachelor’s degree or equivalent

Description du poste

Thermo Fisher Scientific in Belgium is seeking a Regulatory Affairs Manager to lead strategic regulatory decisions supporting product development from preclinical stages through registration and lifecycle optimization. The role emphasizes an operational mindset, ownership of decisions, and cross-functional leadership.

The incumbent will drive regulatory strategy, coordinate global submissions with regulatory authorities and ethics committees, and partner with Clinical Operations to align