Executive/ Senior Executive- Regulatory Affairs Bharat Serums and Vaccines

2.0 - 5.0 years

4 - 6 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.

Posted 1 month 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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Manager Regulatory Affairs Bharat Serums and Vaccines

8.0 - 12.0 years

12 - 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. 11. Tracking and reviewing of document requirements of upcoming new filing in R...

Posted 2 months ago

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Regulatory Affairs Specialist - CMC (USFDA) vueverse.

7.0 - 11.0 years

0 Lacs

hyderabad, telangana

On-site

As a Regulatory Affairs Manager specializing in CMC, you will be responsible for leading and managing all CMC regulatory activities related to USFDA submissions, specifically focusing on ANDA preparation, review, and filing. Your role will involve overseeing the compilation and timely submission of Annual Reports, amendments, and responses to deficiencies. You will collaborate with cross-functional teams such as Quality Assurance, Production, and R&D to gather the necessary documentation and data required for regulatory submissions. A significant aspect of your responsibilities will include reviewing and ensuring compliance of Batch Manufacturing Records (BMR), process validation documents, ...

Posted 3 months ago

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