Executive

1 day ago

Tandalja Vadodara Gujarat, India Sun Pharmaceutical Industries Ltd Full time

**Title**:Executive**:

- Date: Sep 10, 2024- Location: Tandalja - R&D- Company: Sun Pharmaceutical Industries Ltd**Position**: Exe / Sr. Exe (Regulatory Affairs, Baroda)

**Grade **- G12A/G11B

**Education** - B.Pharm / M. Pharm

**Experience** - 4 to 6 years

**Location** - R&D - Baroda
- 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

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