Full-time

Manager - 1

Posted by SUN PHARMA • Tandalja, Gujarat, India

📍 Tandalja, Gujarat 🕒 February 18, 2026

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About the Role

Job Description:

Review all data and documents related to product registrations for various health authorities.

Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel.

Prepare responses to deficiency letters received from various agencies.

Maintain life-cycle / post approval changes for drug product registration dossiers.

Provide regulatory support to cross functional departments.

Prepare and submit scientific advice to various health authorities.

eCTD compilation, verification and submission through electronic gateway

Review, preparation and submission of annual reports to US FDA

Review, preparation and submission of post approval supplements to US FDA

Reviewing of the plant change control and established the variation strategy for submission

Review ...

Job Details

Location Tandalja, Gujarat
Job Type Full-time
Category Other Management Occupations
Posted February 18, 2026
Deadline March 30, 2026

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