Regulatory Project Manager – FSP

Thermo Fisher Scientific

. Guide regulatory activities across medical devices, pharmaceuticals, biologics, and in-vitro diagnostics product lines .

Posted 10/7/2026full-timeRemote • Belgium, France, United Kingdom, NetherlandsMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy development and implementation, with a comprehensive understanding of global regulations and guidelines. Proven ability to manage regulatory submissions and lead cross-functional collaboration while ensuring compliance and driving regulatory excellence.

Highest-signal resume keywords

Regulatory Strategy DevelopmentRegulatory Submissions (IND, BLA, NDA, 510(k), CE Marking)Global Regulations Knowledge (FDA, EMA, PMDA, NMPA)Project Management SkillsRegulatory Affairs Certifications

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsRegulatory Submission PreparationRegulatory Intelligence ManagementGMP/QMS ComplianceAnalytical Skills

Soft Skills

Excellent Communication SkillsProblem-Solving CapabilitiesCollaboration SkillsOrganizational Skills

Tools & Technologies

Regulatory Information Management Systems

Certifications & Qualifications

Regulatory Affairs Certifications

Industry Keywords

Medical DevicesPharmaceuticalsBiologicsIn-Vitro DiagnosticsLife Sciences

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Fully remote work arrangement
Standard Monday-Friday work schedule