Senior Regulatory Affairs
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Parexel is seeking a Senior Regulatory Affairs Associate focused on CMC for biological and vaccine products. This role involves post-approval regulatory activities, collaboration across manufacturing, QA, QC, and regulatory teams, and support for variations, renewals, and market expansions. Remote options in Europe are offered.
The role emphasizes writing and reviewing CMC documentation, managing regulatory information systems, and mitigating regulatory risks in a cross-functional setting.