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- 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 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.
Senior Regulatory Affairs Associate - Hyderabad, India - Parexel
Description
When our values align, there's no limit to what we can achieve.
Regulatory Affairs Labeling