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⏰ Full-time

Associate Director, Regulatory Affairs, CMC

GE HealthCare
Location 📍 Remote, Canada
Posted 📅 June 17, 2026
Work Type ⏰ Full-time

Position Overview

**Job Description Summary**
We are seeking a highly motivated and detail-oriented Regulatory Affairs – CMC professional with a strong background in radiopharmacy or radiopharmaceutical development. The successful candidate will support global regulatory strategy and execution for both marketed and development-stage radiopharmaceutical products involving PET and SPECT tracers. This is a cross-functional role requiring close collaboration with CMC, QA, manufacturing, and supply chain teams to ensure continued regulatory compliance and support for post-approval changes across global markets.

**Job Description**

**Roles and Responsibilities**

+ To be the regulatory CMC strategy point of contact for project teams and to provide CMC related regulatory input for the assigned projects/products.
+ Build, or provide input to, submission strategy documents by defining supplement type, data required to support submission, and submission documents required for the s...

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Job Details

Employment Type
Full-time
📊
Category
other-general
🏠
Work Arrangement
On-site
📍
Location
Remote, Canada