Senior Regulatory Affairs Associate

Job Description

• 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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