Location: Baroda, Gujarat
Position: Regulatory Affairs Specialist
Qualifications: M.Pharm
Experience: 2-5 years
Key Responsibilities:
Data and Document Review: Analyze and review data and documents related to product registrations for various health authorities.
Dossier Compilation: Compile registration dossiers for submission to health authorities, including US-FDA, Health Canada, Europe, Australia/New Zealand, Japan, and Israel.
Response Preparation: Prepare responses to deficiency letters from various regulatory agencies.
Life-Cycle Management: Maintain life-cycle and post-approval changes for drug product registration dossiers.
Regulatory Support: Provide regulatory support to cross-functional departments.
Scientific Advice: Prepare and submit scientific advice to various health authorities.
eCTD Management: Compile, verify, and submit eCTD (Electronic Common Technical Document) submissions through electronic gateways.
How to Apply:
Send your resume to [Hr.tandalja@sunpharma.com]
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