Sr. Director Eu Direct, A&z & Canada

GE HealthCare Technologies

Not specified; not specified; not specified
**
7+ years regulatory affairs experience
Ema and health canada regulatory expertise
Sterile injectables product background
** GE HealthCare Technologies is seeking a Senior Director for Regulatory Affairs, focusing on the EU and Canada, to lead strategic regulatory initiatives for its Pharmaceutical Diagnostics portfolio. The role requires extensive experience in regulatory affairs, particularly in the pharmaceutical industry, along with strong leadership and communication skills. **

Job Summary

  • This Sr. Director role provides senior strategic and operational regulatory leadership for GE HealthCare's Pharmaceutical Diagnostics portfolio across the EU and Canada.
  • The position is accountable for defining and executing regulatory strategies for products in development seeking initial registration as well as legacy products pursuing new indications.
  • The successful candidate will serve as the senior regulatory interface with EMA and national authorities, leading scientific advice and complex negotiations while mentoring a dedicated team.

Matching Summary

Match Score: 75

** GE HealthCare Technologies is seeking a Senior Director for Regulatory Affairs, focusing on the EU and Canada, to lead strategic regulatory initiatives for its Pharmaceutical Diagnostics portfolio. The role requires extensive experience in regulatory affairs, particularly in the pharmaceutical industry, along with strong leadership and communication skills. **

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • 7+ years regulatory affairs experience
  • EMA and Health Canada regulatory expertise
  • Sterile injectables product background
  • Senior leadership and team development
  • Cross-functional clinical and CMC strategy

Nice-to-have

  • Radiopharmaceuticals experience
  • Strategic problem-solving skills
  • Due diligence for acquisitions
  • Budget planning capabilities
  • Complex negotiation with authorities

Key Requirements

  • Bachelor's degree in Life Sciences or Pharmacy
  • Minimum 7 years pharmaceutical regulatory experience
  • Proven leadership experience in the region
  • Experience leading regulatory agency meetings
  • Background in sterile injectables required

Work Rights

Not specified

Tailored Resume

Cover Letter