Senior Regulatory Affairs Associate-- Radiopharmaceuticals

Parexel • Remote (India) • 3w ago

High level of expertise in the lifecycle management of radiopharmaceutical products, including CMC authoring, safety labelling experience, artworks annotations
Assess change controls, author and prepare submission documentation, respond to Health Authority queries
Review published outputs of regulatory packages, management of data submissions to authorities (XEVMPD, PMS, etc.) as requested
Effective communication and collaboration skills, and the ability to work independently.

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