Sr. Regulatory Affairs Executive

• Dec 2018 - Present

Product approval and post approval changes in the European markets in the eCTD & CTD formats. Product approval and post approval changes in the European markets in the eCTD & CTD formats.

Regulatory Affairs Executive

• Nov 2017 - Dec 2018

Executive Regulatory Officer

• Jun 2017 - Nov 2017

Started career in IPQA & QA departments, working in the RA departments since 3.5 years. CTD, ACTD & non-CTD dossier registration to LATAM COUNTRIES: Chile, Mexico, Brazil. Ukraine. ROW countries: Eastern Africa:Phillipines, Vietnam, Singapore, Haiti, Niger,Burkina Faso, Rawada, Costa-Rica, Nigeria. Ukraine. Started career in IPQA & QA departments, working in the RA departments since 3.5 years. CTD, ACTD & non-CTD dossier registration to LATAM COUNTRIES: Chile, Mexico, Brazil. Ukraine. ROW countries: Eastern Africa:Phillipines, Vietnam, Singapore, Haiti, Niger,Burkina Faso, Rawada, Costa-Rica, Nigeria. Ukraine.

Quality Assurance & Regulatory Officer

• Feb 2014 - Jul 2016

 Review of the dossier module 2 & 3 for the CTD dossiers for the ROW countries.  Review, checking of Product Development Report (PDR) .  Handling and Review of Technology Transfer Document.  Review and approval Master formula card and Review of Exhibit Batch Manufacturing Record, Batch manufacturing record of CMO.  Review and approval Process evaluation hold time study, Sampling protocol, Stability protocol.  Review, checking of Analytical Method Validation Protocol and Report.  Review and check of Standard Test Procedure, Specification, COA,  Review and checking daily Analysis report of Assay, Dissolution, RS and Analytical Lab note book.  Review of Stability protocol, specification and stability data.  Handling internal Audit, and contract manufacturer, contract testing lab according to GMP.  Handling change control, Deviation, CAPA and review Supportive document.  Handling Vendor Qualification and Arrangement of Related Documents.  Preparation and review of QA SOP and other GMP Document.  Identification and imparting training for new employee.  Adapt to assigned work like calibration report checking, cleaning verification.  Coordination with Formulation, analytical and Regulatory affairs, CMO for quality, Regulatory compliance, CMC documentation and for dossier filing. Show less

Quality Assurance Officer.

• Aug 2012 - Feb 2014

-IPQA activities: Line clearance, IPQC checks, In process sampling for the QC tests. Involved in the process tech transfer at plants. Method Validation Process. -Preparation of Validation Protocols, Protocols for PDR, BMR, BPRs. Review of Certificate of Specifications, Standard Test Procedures, FP Specifications, Stability Data review. -Preparation of Qualification Protocols & Qualification of Instruments in the Production Areas. -Preparations of SOPs. -Qualification of instruments in Production area. (Compression Machine, Coating rMachines, Hardness Tester, Dissolution Apparatus. -Management of CAPA, Deviations, Change controls etc. -Vendor ratings & evaluations. -Regulatory documentations for the Quality Assurance Departments & Regulatory Compilations. Show less