https://www.facebook.com/Vaishnav.BhagwandaPHARMA JOB AND LEARNING - Bhagwan Das Vaishnav
- Job opening for Assistant Manager - Regulatory Affairs Department in Bliss GVS Pharma Ltd., Andheri.
- Prepared and conducted peer review of quality regulatory submissions (New Dossiers, RTQ, Variations & Renewals) for EU markets to ensure timely approval
- Maintained and completed regulatory documents on a timely basis to support regulatory compliance in EU/Canada/AU markets
- Examined, coordinated and compiled deficiency responses in a timely manner; managed clients query
- Resolved issues related to information for regulatory submissions by working with other functional areas
- Drafted and ensured peer review of labelling, product monographs & marketing materials
- Comprehensive knowledge of Regulatory Software like Docubridge/Educe/PharmaReady etc.
- Reviewing technical specifications, batch manufacturing records, validation protocols & reports, quality documents and change-control procedures
Job Description:
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