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▷ [Only 24h Left] Regulatory Affairs Associate

▷ [Only 24h Left] Regulatory Affairs Associate

PeoplefyIndia
27 days ago
Job description

Hi Everyone,

I am on lookout for Regulatory Affairs Associate for US based, diversified pharmaceutical company in Navi Mumbai.

Please refer below JD and share your profile on

  • Experienced in preparing, review and compile regulatory submissions.
  • Maintain compliance with US FDA and ICH requirements.
  • Should have experienced in pre-submission activity.
  • Experienced in CMC.
  • Prepare, review, and compile regulatory submissions (ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, PADER) in eCTD format.
  • Maintain compliance with US FDA and ICH requirements, including post-approval regulatory filing deadlines.
  • Author and review high-quality CMC documentation, Module 3, and Module 2.3 Quality Overall Summary (QoS).
  • Manage and update labelling components; evaluate and approve changes to approved products for regulatory impact.
  • Review technical documents such as specifications, analytical procedures, batch records, method validation reports, and stability data.
  • Support regulatory strategy by identifying critical issues, responding to FDA queries, and ensuring timely submission of responses.
  • Review and approve change controls from global manufacturing partners to assess regulatory impact.
  • Stay current with FDA guidance, ICH regulations, pharmacopeial requirements, and industry updates.

Thank you!

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