Associate Director, Regulatory Affairs – Clinical Trials (FSP Strategy & Business Development)

Thermo Fisher Scientific · Remote

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Role summary

Thermo Fisher Scientific seeks an Associate Director of Regulatory Affairs for clinical trials to ensure global regulatory compliance and support product lifecycle management. The role involves interpreting regulations, developing regulatory strategies, and collaborating across functions to bring innovative products to market while maintaining patient safety.

What they're looking for

Advanced degree plus 6 years regulatory affairs experience, or bachelor's degree plus 8 years
Background in science, engineering, pharmacy, or related field
Deep knowledge of global regulatory requirements and emerging technologies
Proven experience with regulatory submissions and filings to global authorities
Experience managing regulatory information systems and related software tools
Post-market surveillance and vigilance activity background
Expert communication skills for complex regulatory concepts to diverse audiences

What you'll be doing

Interpret and disseminate global regulations, guidelines, and industry developments to stakeholders
Develop and implement regulatory strategies aligned with business objectives and compliance needs
Evaluate regulatory impact on products and provide strategic recommendations
Support regulatory submissions and maintain compliance throughout product lifecycles
Collaborate with cross-functional teams and regulatory authorities on submissions and policy matters

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Date posted7 days ago

Last source check1 day ago

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