Regulatory Affairs Specialist Iii

PPD (Thermo Fisher)

Cincinnati, US
Not specified
Dea compliance with title 21 cfr part 1300
Controlled substance program management
Arcos reports and biennial inventories
Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist III to ensure compliance with global regulations and facilitate product development related to controlled substances at their Cincinnati location. The ideal candidate will possess strong regulatory knowledge, project management skills, and the ability to collaborate with cross-functional teams

Job Summary

  • The role ensures compliance with global regulations while enabling the mission to make the world healthier, cleaner, and safer.
  • You will serve as the site Controlled Substance Product Coordinator and SME for the site Controlled Substance Program.
  • The position requires coordinating receipt, storage, dispensing, shipment, and record keeping of controlled substances in accordance with federal regulations.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist III to ensure compliance with global regulations and facilitate product development related to controlled substances at their Cincinnati location. The ideal candidate will possess strong regulatory knowledge, project management skills, and the ability to collaborate with cross-functional teams.

Skills & Requirements

Must-have

  • DEA Compliance with Title 21 CFR Part 1300
  • Controlled Substance Program Management
  • ARCOS Reports and Biennial Inventories
  • DEA-222 Forms Preparation and Maintenance
  • Quota Submissions and Year End Reports

Nice-to-have

  • Cross-functional team collaboration skills
  • Strong analytical and problem-solving capabilities
  • Experience leading training programs
  • Ability to prioritize multiple projects
  • Customer-focused mindset with business acumen

Key Requirements

  • Bachelor's degree in Chemistry, Biology, or related field
  • 1+ years experience in DEA Compliance or Regulatory Affairs
  • Proficiency with regulatory submissions software and Microsoft Office

Work Rights

Not specified

Tailored Resume

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