Regulatory Affairs Manager
Pubblicato il 22-09-2026 - Thermo Fisher Scientific in Varese
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Join Us as a Regulatory Affairs Manager
As a Regulatory Affairs Manager, you’ll offer innovative solutions, including regulatory affairs expertise and client interface, to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization.
Beyond regulatory expertise, this position requires a strong operational mindset, decision-making ownership, and cross-functional leadership capability. The Regulatory Affairs Lead (RAL) will own regulatory decision-making for the assigned clinical program and drive the cross-functional clinical trial team toward execution of the regulatory strategy and achievement of program objectives.
Working closely with Clinical Operations and other key functions, the RAL will drive alignment, accountability, and execution across the clinical trial team, ensuring regulatory requirements and dependencies are understood and incorporated into operational plans.
The RAL is expected not only to provide regulatory advice, but also to actively lead the team through regulatory challenges and decisions to maintain progress against agreed study milestones and strategic objectives.
What You’ll Do:
Regulatory Strategy & Decision Ownership
- Own regulatory decision-making for assigned clinical trials and programs, ensuring decisions are consistent with the agreed indication-level regulatory strategy.
- Translate the agreed indication-level strategy into an actionable trial-level regulatory strategy and execution plan, defining regulatory pathways, priorities, deliverables, dependencies, risks, and timelines.
- Provide strategic regulatory intelligence, guidance, and technical expertise to internal and external stakeholders on projects of moderate to high complexity.
- Maintain current knowledge of applicable legislation, regulatory requirements, guidelines, and emerging regulatory developments and transl