Interested candidates kindly send your resume to the following email IDs: [email protected] & [email protected]
Position: Asst. Manager/ Sr.Exexcutive
Qualification : M.Pharm /B.Pharm/M.Sc. having 8+ years experience in US market
Job profile:
- Responsible for the designated regulatory projects with respective deadlines
- Expertise in authoring CMC documentation for ANDA filings and all post-approval submissions
- Good coordination skills 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
- Manage administration of regulatory documentation and ensure the traceability of regulatory history (filing, archiving, database etc)
