Regulatory Affairs Associate

3 weeks ago


Mumbai, Maharashtra, India Parexel Full time

Parexel is seeking a highly skilled Regulatory Affairs Associate to join our team.

Key Responsibilities:

  • 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.
  • Must have handled CCDS related submission/safety variations/PSUR/xEVMPD/label and artwork updates.
  • Co-ordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging.
  • Monitor, manage and control artwork changes.
  • To manage and maintain the Artwork Trackers & Systems.
  • To ensure artwork PDF's are maintained and latest versions are readily available.
  • Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved.


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