Regulatory Affairs Executive

3 days 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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