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Associate Director, Regulatory Affairs, CMC

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GE HealthCare
πŸ“ Remote, Canada
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Location Remote
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Posted June 17, 2026
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Commute Local Area
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Job Description

**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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πŸ“ Location Details

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City
Remote
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Country
Canada
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Commute
Local Area

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