Senior Executive - Regulatory Affairs
SUN PHARMA
Date: 2 weeks ago
City: Vadodara, Gujarat
Contract type: Full time
- Review all data and documents related to product registrations for various health authorities
- Compile registration dossiers for submission to various health authorities like – US, Canada, Europe, Australia & China
- 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
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