Director Ra Osd/api

Thermo Fisher Scientific UK

Ohio, United States
Base: $150,000.00–$218,000.00; bonus/equity: not s...
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6-8 years regulatory affairs experience
Fda ema ich guidelines knowledge
Multi-site team leadership
** Thermo Fisher Scientific is seeking a Director of Regulatory Affairs to lead strategic initiatives ensuring regulatory compliance and driving business growth. The ideal candidate will have extensive experience in pharmaceutical or medical device regulatory affairs, particularly in manufacturing operations, and will manage multi-site teams while influencing global regulatory policy. **

Job Summary

  • This role involves leading strategic initiatives to ensure regulatory compliance while driving business growth across multiple regions.
  • You will oversee regulatory compliance activities, provide expert guidance on requirements, and ensure successful product submissions across various jurisdictions.
  • The position offers the opportunity to influence global regulatory policy and drive innovation in regulatory approaches within a global healthcare context.

Matching Summary

Match Score: 75

** Thermo Fisher Scientific is seeking a Director of Regulatory Affairs to lead strategic initiatives ensuring regulatory compliance and driving business growth. The ideal candidate will have extensive experience in pharmaceutical or medical device regulatory affairs, particularly in manufacturing operations, and will manage multi-site teams while influencing global regulatory policy. **

Salary

Base: $150,000.00–$218,000.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 6-8 years regulatory affairs experience
  • FDA EMA ICH guidelines knowledge
  • Multi-site team leadership
  • Regulatory submission track record
  • Quality management systems expertise

Nice-to-have

  • CDMO or pharmaceutical services background
  • Professional association participation
  • Additional language skills beyond English
  • Strategic thinking in matrix organization
  • Influence on global regulatory policy

Key Requirements

  • Advanced Degree plus 6 years experience OR Bachelor's plus 8 years
  • Life Sciences, Pharmacy, Chemistry, or Microbiology degree preferred
  • Fluency in English required
  • Ability to travel 25-50% internationally

Work Rights

Not specified

Tailored Resume

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