Arun Kumar Email & Phone Number

Hyderabad, In

Hyderabad, Telangana, India

Role in Dossier Preparations: ➢ Responsible for compilation and submission of Dossier (Both CTD & Country Specific) for:African Countries: DR Congo, Kenya, Ghana, Gambia, Togo , Zambia, Guinea, Benin, Nigeria.Asian Countries: Myanmar, Cambodia, Georgia, Afghanistan, Yemen, Tajikistan, Azerbaijan, Uzbekistan, Kazakhstan.South American Countries: Ecuador, Bolivia, Guyana.➢ Responding to queries related to dossiers and other renewal certificates from regulatory agencies.Role in Artworks Development:➢ Coordinating with Q.C department and designer and for artworks development and review of Cartons, Foils, Literature and Labels and Visual aids etc. and approving them.

Hyderabad, Telangana, India

➢ Responsible for compilation and submission of Dossier (Both CTD & Country Specific) for:Asian countries: Myanmar, Cambodia, Malaysia, Philippines, Singapore, Nepal, Afghanistan.African Countries: Ghana, Nigeria and ZambiaMiddle East countries: Iran and Dubai (UAE)CIS Countries: Srilanka, Azerbaijan, Ukraine, Uzbekistan.➢ Responding to queries related to dossiers and other renewal certificates from regulatory agencies.➢ Documents preparing and applying the new and existing certificate. i.e.: FSSAI, FSC, ISO, HACCP, Pharmexcil, WHO-GMP, Trade Marks and GMP-Ayush Licenses, MSME.➢ Reviewing technical documents like Formulation certificate (FC), Master formula record (MFR), Batch manufacturing record (BMR), Stability data, Certificate of analysis (COA), Finishedproduct specification (FP-Spec), Finished product standard testing procedure (FP-STP), process validation.➢ Cross checking RDA value limits in various compositions as per domestic and exports requirements.➢ Tender documents preparing for domestic and export.➢ Supporting business development teams in composition development.➢ Issue the internal dispatch advises for production purpose.➢ Coordinating with the internal departments for various documents for dossier preparations and other certificate renewals.➢ Coordinating with designer for artwork development and review of Cartons, Foils, Literature and Labels and Visual aids etc. and approving them.➢ Preparing Certificate of origin (COO) for export purpose.➢ Sample arrangement for domestic and export and tracking them till it reaching destination.

Hyderabad, Telangana, India

1) Preparing Dossiers and submissions to regulatory authorities for products registration.2) Queries responding related to dossier and renewal certificates.3) Reviewing technical documents like process validation, AMV, Stability data, COA, FP-Specification, FP-STP, MFR, BMR etc.4) Preparing and applying the new and renewal certificates and Maintaining records as assigned. i.e.: GMP, WHO-GMP, GLP, FSC, Repacking license, Market standing certificate,5) Coordinating with internal departments.

Hyderabad, Telangana, India

➢Responsible for dossier compilation and supporting the manager for products registration. (Both CTD & Country Specific) for RAW Market.➢ Compiled and helped in dossier submissions.

Master'S Of Pharmacy, Pharmaceutics

Bachelor Of Pharmacy, Chemistry