Sr Manager, Regulatory Affairs jobs in United States
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Thermo Fisher Scientific · 14 hours ago

Sr Manager, Regulatory Affairs

Thermo Fisher Scientific is a company dedicated to enabling customers to make the world healthier, cleaner, and safer. The Sr Manager, Regulatory Affairs will play a vital role in ensuring compliance and providing strategic regulatory support to project teams in the Drug Substance Division.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
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Responsibilities

Serve as the primary contact for Site Regulatory Affairs
Coordinate regulatory assessments and filing management
Provide strategic regulatory support to project teams

Qualification

Regulatory AffairsCGMP ComplianceLeadershipBiopharmaceutical IndustryGlobal Regulatory RequirementsCommunication SkillsCollaboration

Required

Bachelor's degree in a scientific or related field is mandatory
10+ years in a Quality role in a cGMP environment
5+ years managing people
5+ years regulatory experience in the biopharmaceutical industry
Strong understanding of global regulatory requirements
Highly effective verbal and written communication skills
Collaborative team member with strong communication abilities
Must be legally authorized to work in the United States now and in the future, without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening

Benefits

Competitive remuneration
Annual incentive plan bonus
Healthcare
A range of employee benefits
Relocation assistance may be provided

Company

Thermo Fisher Scientific

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Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Funding

Current Stage
Public Company
Total Funding
$15.97B
Key Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B

Leadership Team

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Marc Casper
CEO
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Stephen Williamson
Senior Vice President and Chief Financial Officer
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Company data provided by crunchbase