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Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing & Controls (CMC)

Organon
Full-time
On-site
hybrid
Other
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Associate Principal Scientist, Regulatory Affairs Chemistry Manufacturing & Controls (CMC)

Company Name: Organon

Job Description

The Associate Principal Scientist is responsible for developing and implementing Regulatory CMC strategies for assigned products. They will lead the preparation and submission of CMC dossiers for programs in clinical development, marketing applications, and post-approval life cycle maintenance. The role involves leading the development and execution of global product and project regulatory strategies, assessing CMC changes, and managing the execution of CMC documentation.