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Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist III to ensure compliance with global regulations related to controlled substances at its Cincinnati facility. The ideal candidate will have experience in regulatory affairs, project management, and strong communication skills to facilitate collaboration across teams.
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Job Summary
This role ensures compliance with global regulations while enabling the mission to make the world healthier, cleaner, and safer.
The specialist acts as the site Controlled Substance Product Coordinator responsible for implementing and maintaining corporate policies.
Key duties include coordinating the receipt, storage, dispensing, and shipment of controlled substances in adherence to Title 21 Code of Federal Regulations.
Matching Summary
Match Score: 75
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Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist III to ensure compliance with global regulations related to controlled substances at its Cincinnati facility. The ideal candidate will have experience in regulatory affairs, project management, and strong communication skills to facilitate collaboration across teams.
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Skills & Requirements
Must-have
DEA 21 CFR Part 1300 compliance
Controlled substance record keeping
ARCOS and Biennial Inventory reports
DEA-222 form preparation
Quota submission management
Nice-to-have
Cross-functional team collaboration
Strong analytical problem solving
Internal audit facilitation skills
Training program development
Strategic regulatory guidance
Key Requirements
Bachelor's degree in Chemistry, Biology, or related field
1+ years experience in DEA Compliance or Regulatory Affairs
Experience with pharmaceutical manufacturing or quality control