Regulatory Affairs Executive

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