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Immacule Life Sciences
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Regulatory Affairs Officer

Regulatory Affairs Officer

Immacule Life Sciences

2 - 4 years

|

1 - 3 Lacs

Posted:Just now| Platform:

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Skills Required

drug regulatory affairs regulatory affairs dossier preparation row market dossier compilation compliance submission dossier row

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities

Prepare dossiers for regulatory submissions, including CTD/eCTD format preparation.
Coordinate with cross-functional teams (QA, QC, Marketing) to obtain necessary documents for dossier compilation.
Ensure compliance with regulatory requirements by reviewing documents such as SOPs, protocols, reports, and batch records.
Review and compile dossiers according to client specifications and timelines.
Maintain accurate records of all activities related to dossier compilation.

Desired Candidate Profile

2-4 years of experience in Regulatory Affairs or a related field (B.Pharma / M.Pharma).
Strong knowledge of drug regulatory affairs in the Row market (European region).
Proficiency in dossier preparation using CTD/eCTD formats.
Excellent understanding of regulatory guidelines from various regions (USFDA, EMA, ANVISA etc.).
Ability to work independently with minimal supervision.

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Immacule Life Sciences

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