Manager Regulatory Affairs - India MArket

Role & responsibilities

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

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.