Vivek Kulshrestha

Biography

Deputy Manager-National Regulatory Affairs Company Name Anthem Biosciences Private Limited Dates Employed Jun 2015 – Present Employment Duration 2 yrs 4 mos Location New Delhi Area, India Dealing with Govt. Authorities Regulatory Affairs Senior Executive Company Name Biocon Dates Employed Aug 2011 – Present Employment Duration 6 yrs 2 mos Location Biocon Ltd, New Delhi 1. Representative of Biocon Ltd at all Govt. regulatory bodies. 2. Applications prepared, reviewed and submission to DCGI Office. 3. Follow up of applications at CDSCO HQ & Zonal Offices, NIB, FSSAI, DBT, ICMR, Deptt. of Animal Husbandry and Fisheries, States Drug Control Deptt. of various states, CBN Gwalior. 4. Various types of applications include Clinical Trial, Market Authorization, Export NOC, Import Licenses, Test Licenses, Manufacturing License and subsequent endorsement etc. 5. Coordination with different Departments like Marketing, R&D, QC and QA within company with respect to Different projects . 6. Proper follow up of implementation of laws as per D&C Act and various other laws. Technical Data Associate (Regulatory Affairs) Company Name Central Drugs Standard Control Organization, FDA, New Delhi Dates Employed Jul 2008 – 2011 Employment Duration 3 yrs Location New Delhi-110002 Technical review of application recieved by Indian Pharma Industry regarding Clinical Trial ,Market Authorization, Test License, NOC (Form 29), CLAA approval for Manufacturing LIcense, Registration, Import License, Export of Biological Samples (DGFT), Global Clinical Trial (Biological), Blood Products, Pharmacovigilance. I have alo experience to work with ADCI , Indira Gandhi International Airport where we regulate Import and export of Drugs. TRAINING & WORKSHOPS 1. Official Training on Quality Assurance IIQM Jaipur November 2009 2 Technical Training on Pharma Regulatory/ Manufacturing CDL Kasauli, Panacea Biotech Lalru, Chandigarh & Panacea Biotech,Baddi , November 2009 3. Successful Participation in NRA Assessment Central Drugs Standard Control Organization, FDA Bhawan, New Delhi. 13 April to 17 April,2009 4.WHO-CDSCO workshop on Marketing Authorization and Licensing. Central Drugs Standard Control Organization, FDA Bhawan, New Delhi. 9 March to 13 March,2009 5.WHO-CDSCO workshop on Marketing Authorization and Licensing. Central Drugs Standard Control Organization, FDA Bhawan, New Delhi. 25th to 29th August 2008 6.Training programm for Technical Data Associate. Central Drugs Standard Control Organization, FDA Bhawan, New Delhi. 25th July 2008 to 01st August 2008 7.Cancer And Its treatment by antimetabolites Deptt of Pharmacy MJP Rohilkhand University, Bareilly B. Pharma IV Yr. 2007 8.GMP Compliance in Non Parentral Dosage form at Panacea Biotech Ltd, new Delhi 1 Months 2007

Research Interest

Pharmaceutical Science