- 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