Regulatory Project Manager – FSP

🔥 0 minutes ago

🌐 Belgium, France, +2 more countries – Remote

🇧🇪 Belgium – Remote 🇫🇷 France – Remote 🇬🇧 United Kingdom – Remote 🇳🇱 Netherlands – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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 • Ensure regulatory requirements are met and 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

🏖️ Benefits

• Fully remote work arrangement • Standard Monday-Friday work schedule