Associate Director, Regulatory Affairs, Cmc

GE HealthCare Technologies

Base: $132,000.00-$198,000.00 annual; bonus/equity...
**
Advanced degree in pharmacy or radiopharmacy
3+ years regulatory affairs experience
Radiopharmaceutical development background
** GE HealthCare Technologies is seeking an Associate Director in Regulatory Affairs, specifically focusing on Chemistry, Manufacturing, and Controls (CMC) within the radiopharmaceutical sector. The ideal candidate will have a strong background in regulatory affairs related to radiopharmaceuticals, with experience in global regulatory strategy and compliance. **

Job Summary

  • The role requires a highly motivated professional to support global regulatory strategy for marketed and development-stage radiopharmaceutical products.
  • Candidates will author and review CMC submission documents while guiding project teams on data collection for various global markets.
  • GE HealthCare offers a competitive benefits package including medical, dental, vision, paid time off, and a 401(k) plan.

Matching Summary

Match Score: 75

** GE HealthCare Technologies is seeking an Associate Director in Regulatory Affairs, specifically focusing on Chemistry, Manufacturing, and Controls (CMC) within the radiopharmaceutical sector. The ideal candidate will have a strong background in regulatory affairs related to radiopharmaceuticals, with experience in global regulatory strategy and compliance. **

Salary

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

Skills & Requirements

Must-have

  • Advanced degree in pharmacy or radiopharmacy
  • 3+ years Regulatory Affairs experience
  • Radiopharmaceutical development background
  • PET and SPECT tracer knowledge
  • Global regulatory submission strategy

Nice-to-have

  • Experience with automated synthesis systems
  • Strong problem-solving and negotiation skills
  • Mentoring team members capability
  • Veeva RIM tool proficiency
  • Matrix organization experience

Key Requirements

  • Doctor of Pharmacy (PharmD) or MSc in radiopharmacy preferred
  • Minimum 3 years experience in Regulatory Affairs or Quality
  • Legal authorization to work in the United States
  • No visa sponsorship provided

Work Rights

Must be legally authorized to work in the United States

Tailored Resume

Cover Letter