Regulatory Affairs Specialist

3 days ago

Vadodara, Gujarat, India Ami Lifesciences Full time ₹ 6,00,000 - ₹ 12,00,000 per year

Role & responsibilities

  • Responsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries.
  • Review and submission of Response to queries raised on DMF by USFDA, and other agencies.
  • Review and submission of Amendments and revisions of Drug Master Files.
  • Review and ensuring the regulatory compliance of CMC information and manufacturing facilities of advanced intermediated through regular visits, which are intended to submit to regulatory markets.
  • Evaluation of cost reductions processes in regulatory point of view and submitting to different regulatory agencies.
  • Review of OOS, BPR, process validation, and other quality assurance documents required for regulatory submissions.
  • Markets Handled: USA, Europe, Canada, Brazil, other ROW etc.

Preferred Candidate

  • Candidate must have experience working in Regulatory Affairs in Pharma API Industry.

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