3-4

Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ/CDSCO-Zonal offices for regulatory approval of drug substance and drug products.

Responsible for preparation of packaging planning on monthly and also daily as per the requirement and availability of materials.

Review and provide technical inputs on Product Development Reports, Master Formula Cards, and Technology Transfer documents

Experience in Review of Data, Audit Tail Review and Release, OOS, 00T, LIR, Empower, LIMS

Experience in RM & PM analysis and document review with expertise in analytical techniques (HPLC, GC, UV, Dissolution), method validation, and regulatory compliance

Having Injectable Experience of Shop floor activities like Filtration, Filling, Sealing, Stoppering, Compounding, Garment Washing, Vial Washing, Autoclave, Ophthalmic, Suspensions, Lyophilizes.

Candidates having Experience on Instrumentation, HPLC, UV, IR, Regulatory Knowledge, GMP Documentation.

Having Injectable Experience of Shop floor supervising activities like filtration, Filling, Sealing, Stoppering, Garment Washing, Vial Washing, Autoclave, Ophthalmic, Suspensions, Lyophilizes. Operations and Training and QMS.

Support Medical Affairs objectives for assigned Cardio-Diabetes / Specialty therapies in emerging markets. Provide scientific and clinical inputs using current guidelines, clinical data, and real-world evidence.