Regulatory Affairs Executive Bharat Serums and Vaccines

2.0 - 6.0 years

6 - 8 Lacs

navi mumbai

Work from Office

Role & responsibilities Preparation and reviewing of CTD and ACTD dossier. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. Co-ordination with plant for Regulatory compliances. Timely achievement of monthly plan & timely query response. Gap Analysis/Updation of Master data. Get feedback from all the countries for respective variation, and their timely submission. Renewals. Master data Updating. Follow ups with plant for documentation regularly and review meeting Expected candidate profile eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, EMA Filings, MCC South Africa for Biological and Biotech products. Has exposure to in-lice...

Posted 3 days ago

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Asst Manager/ Manager- Regulatory Affairs Bharat Serums and Vaccines

8.0 - 12.0 years

11 - 15 Lacs

navi mumbai

Work from Office

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and there timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW a...

Posted 1 month ago

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Assistant Manager Regulatory Affairs- International Bharat Serums and Vaccines

6 - 10 years

8 - 13 Lacs

Navi Mumbai

Work from Office

Role & responsibilities 1. Preparation and reviewing of CTD and ACTD dossier. 2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission. 3. Co-ordination with plant for Regulatory compliances. 4. Timely achievement of monthly plan & timely query response. 5. Gap Analysis/Updation of Master data. 6. Review of Change Controls, Stability Protocol, Clinical Trial Protocols & Artworks. 7. Get feedback from all the countries for respective variation, and their timely submission. 8. renewals. 9. Master data Updating. 10. Follow ups with plant for documentation regularly and review meeting. Tracking and reviewing of document requirements of upcoming new filing in ROW a...

Posted 6 months ago

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