Regulatory Affairs Manager Thermo Fisher · Remote

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 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…