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Aizant
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Executive-Regulatory Affairs(ROW Mkt-Formulations)

Executive-Regulatory Affairs(ROW Mkt-Formulations)

2 - 4 years

|

0 Lacs

Posted:1 week ago| Platform:

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Skills Required

Row CTD Dossier Preparation Regulatory Affairs Row Market Dossier MFC stability

Work Mode

Work from Office

Job Type

Full Time

Job Description

Dear All,

Regulatory Affairs Executive

Hands-on experience in the preparation and submission of regulatory dossiers in CTD and ACTD formats for Rest of the World (ROW) markets.
Proficient in drafting and submitting responses to regulatory queries within stipulated timelines.
Experienced in managing post-approval activities, including renewals and variations.
Skilled in handling Drug Master File (DMF) notifications.
Adept at reviewing and ensuring the accuracy and compliance of quality documents such as product specifications, stability data, Product Development Reports (PDR), Batch Manufacturing Records (BMR), Master Formula Cards (MFC), and process validation protocols.

raghuveera.vutla@aizant.com

Note:

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