Manager - Corporate Regulatory Affairs

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

Skills Required

product registration, dossier submission, regulatory support