The role involves managing the lifecycle of radiopharmaceutical products, authoring submissions, responding to health authority queries, and reviewing regulatory packages.
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
- 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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