Join our collaborative team at Thermo Fisher Scientific as a Senior Manager of Regulatory Affairs, where you'll have a crucial role in ensuring global regulatory compliance and leading strategic initiatives
Job Summary
Join our collaborative team at Thermo Fisher Scientific as a Senior Manager of Regulatory Affairs, where you'll have a crucial role in ensuring global regulatory compliance and leading strategic initiatives.
This position offers the opportunity to make a significant impact on bringing innovative scientific solutions to market while ensuring compliance with evolving global regulations.
You'll collaborate with Quality, R&D, Marketing, and other stakeholders to ensure regulatory requirements are met throughout product development and commercialization.
Matching Summary
Join our collaborative team at Thermo Fisher Scientific as a Senior Manager of Regulatory Affairs, where you'll have a crucial role in ensuring global regulatory compliance and leading strategic initiatives.
Skills & Requirements
Must-have
Global regulatory compliance
Regulatory submissions expertise
Project management skills
Cross-functional collaboration
Regulatory intelligence activities
GMP/QMS compliance knowledge
Regulatory strategy development
Nice-to-have
Leadership and staff management
Strong analytical and problem-solving
Superior communication skills
Ability to influence organization
Proficiency with regulatory systems
Business-level English proficiency
Willingness to travel 20%
Key Requirements
Advanced Degree plus 6 years experience or Bachelor's plus 8 years
Regulatory affairs certifications beneficial
Comprehensive knowledge of FDA, EMA, PMDA, NMPA regulations
Experience with IND, BLA, NDA, 510(k), CE marking submissions