Regulatory Affairs Manager

02 ott - Roma
Thermofisher Scientific

Work Schedule

Le seguenti informazioni forniscono una panoramica delle competenze, delle qualità e delle qualifiche necessarie per questo ruolo.
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

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- 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

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- 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 mu

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