Senior Regulatory Affairs Associate Radiopharmaceuticals
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Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were 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.
Required Experience:
Senior IC
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
