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.
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.
Own regulatory decision-making for assigned clinical trials and programs, ensuring decisions are consistent with the agreed indication-level regulatory strategy.
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 translate these into relevant strategic and operational guidance.
Serve as a regulatory subject-matter expert across global, regional, and country-specific requirements.
Partner closely with Clinical Operations and other functions to integrate regulatory requirements, dependencies, risks, and timelines into study operational plans.
Establish clear regulatory priorities and accountabilities across the clinical trial team and proa

📌 Regulatory Affairs Manager (Italia)
🏢 Thermo Fisher Scientific
📍 Italia