Senior Regulatory Project Manager
Thermo Fisher Scientific
Thermo Fisher Scientific seeks a Senior Manager of Regulatory Affairs to lead regulatory compliance and strategy across multiple product lines including medical devices, pharmaceuticals, biologics, and diagnostics. The role involves guiding global regulatory activities, managing submissions, and collaborating with cross-functional teams to bring innovative solutions to market while ensuring compliance.
Responsibilities
Provide strategic regulatory guidance and lead regulatory submission preparations across product lines
Develop and implement regulatory strategies supporting product development, registration, and lifecycle management
Collaborate with Quality, R&D, Marketing, and stakeholders to ensure regulatory compliance throughout commercialization
Conduct regulatory intelligence activities and manage interactions with regulatory authorities
Manage and develop regulatory affairs staff while overseeing multiple concurrent projects
Requirements
Advanced degree plus 6 years experience, or bachelor's degree plus 8 years in regulatory affairs for pharma, medical device, or diagnostics
Life sciences, chemistry, engineering, pharmacy, or related scientific background
Comprehensive knowledge of global regulatory frameworks (FDA, EMA, PMDA, NMPA)
Expertise in regulatory strategy development and submission management (IND, BLA, NDA, 510(k), CE marking)
Proven experience managing regulatory affairs staff and interacting with regulatory authorities
Advanced GMP/QMS knowledge with strong project management and communication skills
Business-level English proficiency; regulatory certifications and additional languages beneficial
L'offre d'emploi a été publiée il y a 2 jours
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