EXECUTIVE
SUN PHARMA
Date: 2 weeks ago
City: Vadodara, Gujarat
Contract type: Full time
Position : Exe / Sr. Exe (Regulatory Affairs, Baroda)
Grade – G12A/G11B
Education – B.Pharm / M. Pharm
Experience – 4 to 6 years
Location – R&D - Baroda
Job Description:
Grade – G12A/G11B
Education – B.Pharm / M. Pharm
Experience – 4 to 6 years
Location – R&D - Baroda
Job Description:
Grade – G12A/G11B
Education – B.Pharm / M. Pharm
Experience – 4 to 6 years
Location – R&D - Baroda
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
Grade – G12A/G11B
Education – B.Pharm / M. Pharm
Experience – 4 to 6 years
Location – R&D - Baroda
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
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