Regulatory Affairs Executive

3 months ago


Mumbai, India Ipca Laboratories Limited Full time

Position : Executive - Regulatory affairs formulation for USA market.


Qualification : B.Pharm/M.Pharm


Experience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.


Role:

  • Preparation of registration dossiers as per the US Regulatory guidelines
  • Preparation of renewal application as per Renewal guidelines
  • Facilitate query response raised by regulatory authority and customers
  • Preparation and submission of Safety, Quality & Administrative variations as per variation guidelines


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