Associate Director, Regulatory Affairs, Marketed Products Portfolio

GE HealthCare Technologies

Base: $132,000.00-$198,000.00 annual; bonus/equity...
Not specified
5+ years regulatory affairs experience
Fda and health canada submission expertise
New product development lifecycle management
GE HealthCare Technologies is seeking an Associate Director of Regulatory Affairs to lead regulatory strategy and execution for its Pharmaceutical Diagnostics portfolio. The role involves ensuring compliance for new product development and lifecycle management, primarily focusing on U.S. and Canadian markets

Job Summary

  • This role drives regulatory strategy and execution for new product development and lifecycle management of marketed products across global markets.
  • The incumbent will serve as the face of Regulatory Affairs on cross-functional teams, ensuring timely submissions, approvals, and compliance.
  • GE HealthCare offers a competitive benefits package including medical, dental, vision, paid time off, and a 401(k) plan with company contributions.

Matching Summary

Match Score: 85

GE HealthCare Technologies is seeking an Associate Director of Regulatory Affairs to lead regulatory strategy and execution for its Pharmaceutical Diagnostics portfolio. The role involves ensuring compliance for new product development and lifecycle management, primarily focusing on U.S. and Canadian markets.

Salary

Base: $132,000.00-$198,000.00 Annual; Bonus/Equity: Performance based incentive compensation eligible; Benefits: Medical, dental, vision, 401(k), life insurance

Skills & Requirements

Must-have

  • 5+ years regulatory affairs experience
  • FDA and Health Canada submission expertise
  • New product development lifecycle management
  • INDs, CTAs, CBEs, PAS document preparation
  • Sterile injectables or radiopharmaceutical background

Nice-to-have

  • Strategic thinker with analytical skills
  • Strong negotiation and communication abilities
  • Proactive risk management mindset
  • Experience in multinational environments
  • Due diligence for acquisitions and licensing

Key Requirements

  • Bachelor's degree in Life Sciences or Pharmacy
  • Advanced degree preferred
  • Authorized to work in the United States
  • No visa sponsorship available

Work Rights

Must be legally authorized to work in the United States

Tailored Resume

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