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Regulatory Affairs Analyst

Mid-level
๐Ÿ‡ฎ๐Ÿ‡ณ India
Healthcare
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  • Should have an experience in Europe market pre/post approval submissions
  • Evaluation of Europe post approval changes with precise classification and documentation.
  • Preparation, review and submission of variations and renewals for EU market
  • Timely interaction with overseas colleagues on updates/approvals
  • Handling of deficiencies and timely response to regulatory agencies
  • Good interpersonal skills with command on English language to communicate with Regulatory agencies & IL Customers
  • Providing regulatory guidance/regulatory strategies to IL partner and other cross functional teams
  • Support the manufacturing sites during Regulatory audits
  • Should have the sound knowledge on GMP/QMS/Plant operations

Requirements

Master of Pharmacy

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Dr Reddy's Laboratories Limited

Dr Reddy's Laboratories Limited

A leading multinational pharmaceutical company based across global locations, focused on accelerating access to affordable and innovative medicines.

๐ŸฅGood health and wellbeing
Pharmaceuticals
Research and Development (R&D)

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