Deepak Kumar Email & Phone Number

• Looking for opportunity in Regulatory Affairs1) Review all data and documents related to product registrations for various health authorities.2) Compile registration dossiers for submission to various health authorities like -ROW Market, Latin America, Guatemala, Dominican Republic, 3) Prepare responses to deficiency letters received from various agencies.Maintain life-cycle / post approval changes for drug product registration dossiers.4) Provide regulatory support to cross functional departments.5) Prepare and submit scientific advice to various health authorities.• Operational knowledge of analytical instruments like HPLC,GC, UV, FTIR, DT Apparatus, Dissolution Apparatus, Karl Fisher titrator, Bulk density apparatus and Particle Size Analyzer and various others.• Extensive knowledge and experience in Laboratory and working in accordance with GLP and GMP requirements.• Highly motivated and committed to delivering top quality services to Pharmaceutical Industry.• Able to work under pressure and perform multiple tasks at once.• Continually promotes concepts of integrity, quality, and teamwork.• Wide knowledge of GMP, GLP, SOP, ICH Guidelines, USFDA Health and safety.• Computer skills include: EM Power software for HPLC, Shimadzu software for UV, MS Office, MS Word, MS Excel and internet /Email etc.

Listed skills include Microsoft Office, Microsoft Excel, Project Management, Microsoft Word, and 17 others.