Senior Regulatory Affairs Associate Labelling
Senior Regulatory Affairs Associate Labelling
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Job Description
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.
Regulatory Affairs expertise with medicinal products for changes with impact on Product Information Safety / Labelling changes including CCDS creation or updates
Experience:
1. 47 yrs of Regulatory Affairs experience in EU/UK/CH/AU/NZ:
Safety Labelling changes with impact on Product Information and management of AW updates from an RA perspective
CCDS creation or updates prior experience preferable
Change control assessments
Experience working on Centralized products is a plus
2. Veeva RIMS Knowledge.
3. Knowledge in using TVT Tool is a plus.
Required Experience:
Senior IC
Employment Type
Full Time
