Manager - Corporate Regulatory Affairs

SUN PHARMA


Date: 1 week 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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