Roles and Responsibilities :
Experienced in Regulatory filings to CDSCO - Recent applications, Query responses, Renewals and variation applications.
Experience in Applications for nutraceuticals and /vaccines will be an added advantage
Experience in ROW Markets will be an added advantage.
Submission and approvals of Form 45, Form 40 and Form 10.
Renewals and Variation (Minor and Major) applications and approvals
Nutraceuticals and import packager applications
Answering Agency queries related to above applications
Travel to CDSCO/ any other Indian regulatory Agency as and when required to get the required information or guidance related to pipeline applications.
Communication with the CDSCO, CDTL, IVRI, FSSAI and any other related Agency in India for any filing related matters and getting approvals
Co-ordination with cross functional teams and Regulatory support to Business and/ commercial queries
Having basic knowledge required to regulatory for import/ export and complete knowledge of working on SUGAM Portal

📌 Manager Regulatory Affairs Mumbai (India)
🏢 Alivira Animal Health
📍 India