Position: Sr.Officer/ Executive
Qualification : M.Pharm /B.Pharm/M.Sc. having 4-6 years experience in US market
Job profile:
- Author and compile CMC documentation for ANDA filings and post-approval submissions
- Coordination with stakeholders on regular basis to source the documents in accordance with project timelines
- Review the documents against the FDA guidances assuring regulatory compliance
- Keep knowledge up to date with regard to regulatory guidelines
- Hands-on experience on using eCTD software
