Manager - Corporate Regulatory Affairs
SUN PHARMA
Date: 1 day ago
City: Vadodara, Gujarat
Contract type: Full time
Job Description
- Preparation of registration strategy for various health authorities like Brazil and other Latin American countries i.e. Peru, Ecuador, Colombia, Panama
- Adequate understanding on Brazil guidance and filing of new product and post approval changes
- Review of documents related to product registration and dossier submission leading to faster approval
- Prepare response to deficiency letter received from various agencies
- Maintain life-cycle / post approval changes for drug product registration dossiers including timely circulation of approval information
- Provide regulatory support to cross functional department
- Adequate assessment of change control as per regulatory guidance
- Prepare and submit scientific advice to various health authorities
- Compilation, verification and submission through electronic gateway
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