Regulatory Project Manager – FSP – EMEA

🔥 8 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Ensure global regulatory compliance and lead strategic regulatory initiatives • Guide regulatory activities across medical devices, pharmaceuticals, biologics, and in-vitro diagnostics product lines • Develop and implement regulatory strategies supporting product development, registration, and lifecycle management • Provide strategic regulatory guidance • Lead regulatory submission preparations • Interact with regulatory authorities • Manage regulatory intelligence activities • Collaborate with Quality, R&D, Marketing, and other stakeholders throughout product development and commercialization • Drive regulatory excellence across the organization • Manage and develop regulatory affairs staff • Manage multiple regulatory projects simultaneously

🎯 Requirements

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in regulatory affairs in pharmaceutical, medical device, or diagnostics industry • Preferred Fields of Study: Life Sciences, Chemistry, Engineering, Pharmacy or related scientific field • Regulatory affairs certifications beneficial • Comprehensive knowledge of global regulations and guidelines (FDA, EMA, PMDA, NMPA) • Demonstrated expertise in regulatory strategy development and implementation • Strong experience with regulatory submissions (IND, BLA, NDA, 510(k), CE marking) • Proven track record of successful interactions with regulatory authorities • Experience managing and developing regulatory affairs staff • Advanced understanding of GMP/QMS requirements and compliance • Excellent project management and organizational skills • Strong analytical and problem-solving capabilities • Superior written and verbal communication skills • Ability to influence and collaborate across all organizational levels • Proficiency with regulatory information management systems • Proven ability to manage multiple projects simultaneously • Available for approximately 20% travel • Business-level English proficiency required, additional languages beneficial

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