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Immacule Life Sciences
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Regulatory Affairs Assistant Manager

Regulatory Affairs Assistant Manager

Immacule Life Sciences

8 - 13 years

|

8 - 13 Lacs

Posted:Just now| Platform:

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Skills Required

regulatory affairs anda us market drug regulatory affairs dossier injectables

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities

Manage regulatory dossiers (eCTD) submission for ANDA, DMF, and other products.
Coordinate with cross-functional teams to ensure timely submission of regulatory applications.
Review and manage variations, renewals, extensions, and post-marketing requirements.
Prepare and review CTD modules for marketing authorizations.
Ensure compliance with FDA regulations and guidelines.

Desired Candidate Profile

8-13 years of experience in Regulatory Affairs or related field.
B.Pharma degree from a recognized institution.
M.Pharma degree preferred but not mandatory.
Strong understanding of drug regulatory affairs, injectables, and US market knowledge.

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Immacule Life Sciences

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