Job Description

Position : Exe / Sr. Exe (Regulatory Affairs, Baroda)Grade - G12A/G11BEducation - B.Pharm / M. PharmExperience - 4 to 6 yearsLocation - R&D - Baroda:

• 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

Position : Exe / Sr. Exe (Regulatory Affairs, Baroda)Grade - G12A/G11BEducation - B.Pharm / M. PharmExperience - 4 to 6 yearsLocation - R&D - Baroda:

• 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

Sun Pharmaceutical Industries