1) Following up with the CDSCO(DCGI), CDSCO (Zonal office),IPC, State FDA(DCA), NPPA, CBN and all govt. authorities for the processing of applications of New drug, subsequent New drug, Fixed dose Combination (FDC), Biologic and Blood Products .2) Preparation and reviewing application for Manufacturing and Marketing of New Drug and Subsequent New Drug (CDSCO Form CT-21) 3) Preparation and reviewing applications for Import and Marketing of New Drug (CDSCO Form CT-18) 4) Preparation… Show more 1) Following up with the CDSCO(DCGI), CDSCO (Zonal office),IPC, State FDA(DCA), NPPA, CBN and all govt. authorities for the processing of applications of New drug, subsequent New drug, Fixed dose Combination (FDC), Biologic and Blood Products .2) Preparation and reviewing application for Manufacturing and Marketing of New Drug and Subsequent New Drug (CDSCO Form CT-21) 3) Preparation and reviewing applications for Import and Marketing of New Drug (CDSCO Form CT-18) 4) Preparation and Presenting Firm Proposal to SEC Committee to substantiate Firm Application to CDSCO.5) Preparing and reviewing application for New Drug Product Manufacturing Permission and Approved Drug Product Manufacturing Permissions (CDSCO Form CT-10, Form CT-16, Form 12, Form CT-05 and Form 29).8) Preparing and reviewing application for Import NOC and Export NOC.10)Submissions of all applicable applications online via Sugam Portal. Prepare and submit the query responses as and when required online.11) Submissions of BE-NOC/CT NOC amendments, Notifications and EC approved Protocols to CDSCO office.12) Involved in co-ordination with Plant, R&D and QA-QC Department for review, preparation and collection of documents.13) Tracking of Projects by excel sheets, coordinating with Project managers for timely delivery of Projects.14) Frequent teleconference with various team for smooth progress of Projects. 15) Prepare, review and maintain an archival of applications, approvals received from CDSCO. 16) Maintaining relations with Regulatory Officials i.e. Drug Inspector, Assistant Drug Controllers etc. of various departments to resolve the issues related to any kind of permission, NOCs, & Licenses; preparing, reviewing, submitting technical and other documents/ dossiers with Drug Controller General of India/ CDSCO/State FDAs, IPC for-Registration for import of Pharmaceuticals Formulations and Bulk Drugs. Show less

Compilation and review of the documents that are meant for the submission to the FDA,DCGI, CDSCO, New Delhi, it includes the various applications for the purpose of conducting clinical trials, BE study, permission for manufacturing of New Drugs, subsequent new drug, Import license & registration, Export NOC, FDC approvals, Ethics committee approval/renewal, Test licenses.• Preparation of application on Form 12, 40, 44, CT and BE study, registration, query reply, addition documents… Show more Compilation and review of the documents that are meant for the submission to the FDA,DCGI, CDSCO, New Delhi, it includes the various applications for the purpose of conducting clinical trials, BE study, permission for manufacturing of New Drugs, subsequent new drug, Import license & registration, Export NOC, FDC approvals, Ethics committee approval/renewal, Test licenses.• Preparation of application on Form 12, 40, 44, CT and BE study, registration, query reply, addition documents for NOC, Licenses and renewal of licenses wherever applicable.• Successfully completed CT and BE study and submit the report to DCGI for approval of new drug (First time in India)• Coordination with QA/QC and other department’s personals for the various document requirements to compile the applications.• Preparation of documents and compilation for Product Approval/NOC from FSSAI, New Delhi.• Coordination with Patent team to resolve their queries.• Regular follow up to the CDSCO and FSSAI, FDA Bhawan, New Delhi, for the processing of applications.• Maintaining relations with Regulatory officials of various departments to resolve the issues related to any kind of permission, NOCs, & Licenses. Preparation, Review, Submission of Technical and other Documents/Dossiers with Drug Controller General of India/CDSCO/State FDAs for--Registration for import of pharmaceuticals Formulations and bulk drugs.• Import Licenses-Manufacturing & Marketing licenses, No Objection Certificates etc.• Liasioning with Government Authorities for regulatory approval ie. DCGI/CDSCO/state FDA offices/Directorate. Show less

Compilation and review of the documents that are meant for the submission to the FDA,DCGI, CDSCO, New Delhi, it includes the various applications for the purpose of conducting clinical trials, BE study, permission for manufacturing of New Drugs, subsequent new drug, Import license & registration, Export NOC, FDC approvals, Ethics committee approval/renewal, Test licenses.• Preparation of application on Form 12, 40, 44, CT and BE study, registration, query reply, addition documents… Show more Compilation and review of the documents that are meant for the submission to the FDA,DCGI, CDSCO, New Delhi, it includes the various applications for the purpose of conducting clinical trials, BE study, permission for manufacturing of New Drugs, subsequent new drug, Import license & registration, Export NOC, FDC approvals, Ethics committee approval/renewal, Test licenses.• Preparation of application on Form 12, 40, 44, CT and BE study, registration, query reply, addition documents for NOC, Licenses and renewal of licenses wherever applicable.• Successfully completed CT and BE study and submit the report to DCGI for approval of new drug (First time in India)• Coordination with QA/QC and other department’s personals for the various document requirements to compile the applications.• Preparation of documents and compilation for Product Approval/NOC from FSSAI, New Delhi.• Coordination with Patent team to resolve their queries.• Regular follow up to the CDSCO and FSSAI, FDA Bhawan, New Delhi, for the processing of applications.• Maintaining relations with Regulatory officials of various departments to resolve the issues related to any kind of permission, NOCs, & Licenses. Preparation, Review, Submission of Technical and other Documents/Dossiers with Drug Controller General of India/CDSCO/State FDAs for--Registration for import of pharmaceuticals Formulations and bulk drugs.• Import Licenses-Manufacturing & Marketing licenses, No Objection Certificates etc.• Liasioning with Government Authorities for regulatory approval ie. DCGI/CDSCO/state FDA offices/Directorate. Show less

Compilation and review of the documents that are meant for the submission to the FDA,DCGI, CDSCO, New Delhi, it includes the various applications for the purpose of conducting clinical trials, BE study, permission for manufacturing of New Drugs, subsequent new drug, Import license & registration, Export NOC, FDC approvals, Ethics committee approval/renewal, Test licenses.• Preparation of application on Form 12, 40, 44, CT and BE study, registration, query reply, addition documents… Show more Compilation and review of the documents that are meant for the submission to the FDA,DCGI, CDSCO, New Delhi, it includes the various applications for the purpose of conducting clinical trials, BE study, permission for manufacturing of New Drugs, subsequent new drug, Import license & registration, Export NOC, FDC approvals, Ethics committee approval/renewal, Test licenses.• Preparation of application on Form 12, 40, 44, CT and BE study, registration, query reply, addition documents for NOC, Licenses and renewal of licenses wherever applicable.• Successfully completed CT and BE study and submit the report to DCGI for approval of new drug (First time in India)• Coordination with QA/QC and other department’s personals for the various document requirements to compile the applications.• Preparation of documents and compilation for Product Approval/NOC from FSSAI, New Delhi.• Coordination with Patent team to resolve their queries.• Regular follow up to the CDSCO and FSSAI, FDA Bhawan, New Delhi, for the processing of applications.• Maintaining relations with Regulatory officials of various departments to resolve the issues related to any kind of permission, NOCs, & Licenses. Preparation, Review, Submission of Technical and other Documents/Dossiers with Drug Controller General of India/CDSCO/State FDAs for--Registration for import of pharmaceuticals Formulations and bulk drugs.• Import Licenses-Manufacturing & Marketing licenses, No Objection Certificates etc.• Liasioning with Government Authorities for regulatory approval ie. DCGI/CDSCO/state FDA offices/Directorate. Show less

Nature of Work:Reviewing the dossiers submitted by the firms w.r.t New drugs, FDCs, Subsequent new Drugs (SND) Import and Export of Drugs, Cosmetics & Medical Devices, BA/BE Centre Approval, Form-29 (NOC), Form 11, New Drug Trial Approval and Marketing Approval, Parliamentary matters, legal matters and other works as assigned by the DCG (I) from time to time.Experience of regulatory issues and their resolution with respect to New Drugs / FDC /SND/ Clinical trial / BE Studies at… Show more Nature of Work:Reviewing the dossiers submitted by the firms w.r.t New drugs, FDCs, Subsequent new Drugs (SND) Import and Export of Drugs, Cosmetics & Medical Devices, BA/BE Centre Approval, Form-29 (NOC), Form 11, New Drug Trial Approval and Marketing Approval, Parliamentary matters, legal matters and other works as assigned by the DCG (I) from time to time.Experience of regulatory issues and their resolution with respect to New Drugs / FDC /SND/ Clinical trial / BE Studies at CDSCO.At the FDC’s Division of FDA, involved in technical review for Dossiers intended for Clinical Trials of FDC’s Preparations.Screening the new applications and query reply by the company in pre-screening department of FDA.Processing and reviewing of application and reported to Assistant Drug controller (India) and Drug Inspectors. Show less

Drug manufacturing