Strategic CMC Regulatory Lead

Strategic CMC Regulatory Lead

Full-Time 103500 - 126500 $ / year (est.) On-site
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At a Glance

  • Tasks: Lead CMC regulatory strategies and maintain quality sections of product dossiers.
  • Company: Join GE HealthCare, a leader in innovative diagnostics.
  • Benefits: Competitive salary, health benefits, and opportunities for professional growth.
  • Other info: Dynamic work environment with a focus on innovation and collaboration.
  • Why this job: Make a significant impact in healthcare by ensuring compliance and quality.
  • Qualifications: Experience in regulatory management and strong understanding of CMC guidelines.

The predicted salary is between 103500 - 126500 $ per year.

GE HealthCare in the United States is seeking a Senior Regulatory Manager to provide CMC regulatory input and to develop and maintain the Quality sections of product dossiers (Module 2.3 and 3) throughout the life cycle.

The role involves:

  • Guiding submission strategies
  • Coordinating with Global Regulatory Lead
  • Drafting or editing CMC dossier sections
  • Supporting audits and inspections while staying current with regulatory guidelines

Strategic CMC Regulatory Lead employer: GE HealthCare

GE HealthCare is an exceptional employer that prioritizes employee growth and development within a collaborative and innovative work culture. As a leader in medical technology, we offer competitive salaries, comprehensive benefits, and the opportunity to make a meaningful impact on healthcare in Canada. Join us to unlock your potential and contribute to a healthier world while working alongside passionate professionals who value integrity and teamwork.

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Contact Details:

GE HealthCare Recruitment Team

We think you need these skills to ace Strategic CMC Regulatory Lead

Regulatory Knowledge
CMC Regulatory Input
Quality Management
Dossier Development
Submission Strategies
Coordination Skills
Drafting and Editing Skills