Regulatory affairs manager

01 ott - Italia
Thermofisher Scientific

Work Schedule
Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life—enabling our customers to make the world healthier, cleaner and safer.
With clinical trials conducted in 100+ countries and ongoing development of innovative frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. We are currently seeking a Regulatory Affairs Manager to join our global Regulatory Affairs department, Regulatory Science team. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting.
In this role, you will be part of a global team providing innovative regulatory solutions, owning regulatory affairs responsibilities, and leading discussions with internal and external clients. You will coordinate global regulatory strategies on assigned (Phase 1–4) clinical trials,



studies, and projects, supporting clients with strategic regulatory intelligence and guidance throughout clinical development.
Role Focus at This Level This position sits within our senior individual contributor framework In this Manager role, the emphasis is on oversight across multiple projects, client engagement, and accountability for delivery, scope, and financial elements .
Responsibilities
Lead the preparation of global regulatory submissions for CTA and ensure high quality standards that meet local and regional requirements. Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and for key client projects of moderate to high complexity. Provide oversight across multiple studies/projects , ensuring alignment of regulatory strategy, quality, and delivery.
Act as a senior client-facing lead , contributing to broader r

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