Senior Regulatory Project Manager

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

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. You'll guide regulatory activities across multiple product lines including medical devices, pharmaceuticals, biologics, and in-vitro diagnostics. Working closely with cross-functional teams, you'll develop and implement regulatory strategies to support product development, registration, and lifecycle management. This position offers the opportunity to make a significant impact on bringing innovative scientific solutions to market while ensuring compliance with evolving global regulations.

In this role, you'll provide strategic regulatory guidance, lead submission preparations, interact with regulatory authorities, and manage regulatory intelligence activities. You'll collaborate with Quality, R&D, Marketing, and other stakeholders to ensure regulatory requirements are met throughout product development and commercialization. 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

• Regulatory affairs certifications beneficial
• Experience managing and developing regulatory affairs staff
• Advanced understanding of GMP/QMS requirements and compliance
• Excellent project management and organizational skills
• Proficiency with regulatory information management systems
• Proven ability to manage multiple projects simultaneously
• Business-level English proficiency required, additional languages beneficial