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    Senior Regulatory Affairs Associate - Hyderabad, India - Parexel

    Parexel
    Parexel Hyderabad, India

    5 days ago

    Default job background
    Local Office
    Description

    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 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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