Manager - Regulatory Affairs

Roles and Responsibilities :

• Experienced in Regulatory filings to CDSCO - New 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