Associate Director, Regulatory Affairs, CMC
Location
Remote, PQ
Job Type
Full-time
Category
other-general
Posted
June 17, 2026
**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...
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...