Senior Regulatory Affairs Associate

3 weeks ago


Hyderabad, Telangana, India Parexel Full time

Regulatory Affairs Labeling

Bachelor's Degree plus at least 5 to 8 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 past experience creating annual reportsThe ability to collaborate with Tech Ops for artwork implementationProficiency 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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