Senior Regulatory Affairs Associate- Labeling

1 week ago


Bengaluru, Karnataka, India Parexel Full time

When our values align, there's no limit to what we can achieve.

Regulatory Affairs Labeling

Must have 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging) The ability to research and create comparator labeling documents. Strong understanding and experience creating annual reports. The ability to collaborate with Tech Ops for artwork implementation. Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system. Electronic document management systems use and / or electronic submission experience. Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.

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