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The Pharma Patashala
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Regulatory affairs Senior Manager

Regulatory affairs Senior Manager

The Pharma Patashala

16 - 20 years

|

15 - 20 Lacs

Posted:9 hours ago| Platform:

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Skills Required

regulatory guidelines documentation regulatory affairs api bulk drugs warehouse problem solving hr operations gmp qc analysis qa/qc api production active pharmaceutical ingredient quality assurance dmf api manufacturing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities

Review documents from various departments to compile regulatory submission.
Oversee drug master file for submission to regulatory authorities, including updates, amendments, and revisions as required.
Draft both the applicant and restricted parts of DMF s to ensure regulatory complience.
Coordinate with CFT to address deficiency and feedback from RA and customers.
Conduct CFT meetings to ensure timely responses to regulatory deficencies and customer inquires.
Provide regulatory guidance to product development teams and attend technology transfer meetings to support compliance.
Respond promptly to technical queries from regulatory bodies and customers.

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The Pharma Patashala

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