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Bharat Serums and Vaccines
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Regulatory Affairs Executive

Regulatory Affairs Executive

Bharat Serums and Vaccines

2 - 6 years

|

6 - 8 Lacs

Posted:-1 days ago| Platform:

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Skills Required

biotech products biological products ich requirements actd gap analysis usfda ctd out licensing in licensing ema filings

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

Biological and Biotech products.

Has exposure to in-licensed dossier filing and out licensing

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Bharat Serums and Vaccines

Biopharmaceuticals

Mumbai

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