Senior Executive

• Jan 2019 - Present

Senior Executive

• Feb 2017 - Jan 2019

Senior Officer

• Mar 2016 - Sep 2016

Building Regulatory Strategy for drug product development to be registered in regulated markets like US and Europe. WHO-PQ filings and variation filing. CMC review. Dossier preparation and review for ROW markets like African, ASEAN, CIS and LATAM. Building Regulatory Strategy for drug product development to be registered in regulated markets like US and Europe. WHO-PQ filings and variation filing. CMC review. Dossier preparation and review for ROW markets like African, ASEAN, CIS and LATAM.

Research scientist

• Aug 2013 - Mar 2016

Preparation of Dossiers for Human Drug Products for Asian, African, CIS, European and U.S. markets. Preparation of Dossiers for Human Drug Products for Asian, African, CIS, European and U.S. markets.

Regulatory Affairs Trainee

• Nov 2012 - May 2013

Preparation of Dossiers as per A-CTD, Non-CTD, CIS guidelines. Comparative understanding among CTD Guidelines with that of mentioned above. Reviewing of Technical & Administrative Documents required for filing of Dossiers for the registration of Conventional dosage forms e.g. Tablets, Capsules, Parenterals, Creams & Oral suspensions; Medical Devices & Diagnostic kits. Learning towards planning Regulatory Strategy for New Products. Exposure towards filing of Dossiers in various Asian, East & West African and CIS Countries. Show less

Research Project Trainee

• Jul 2011 - May 2012

Performed my Research Project Training in CSIR-CDRI for grooming my knowledge across the dimensions of Research & completed my Dissertation for M.Pharm Project. Title: Formulation & characterization of microballoons bearing an antibiotic solid dispersion, comperaed with that with of antibiotic. At CSIR-CDRI (Central Drug Research Institute), Lucknow, Uttar Pradesh) formulation and characterization of novel drug delivery system (Microballoons) of an antibiotic. To plan bioequivalence and bioavailability studies on drug products and evaluate the respected data to recommend changes in formulation by varying parameters. To generate and review analytical data to support the product development work. To perform appropriate documentation to develop and maintain appropriate research protocol. Expertise in formulation and development of conventional as well as novel drug delivery systems (micro- and nano-based) in respect of oral, parenteral and topical routes with its proper evaluation skills in vitro and in vivo. Basic handling of modern scientific analytical instruments like HPLC (High Performance Liquid Chromatography), FTIR (Fourier-Transform Infrared Spectroscopy), Ultra-violet (UV) spectroscopy, Rota vapour, Microfluidizer, Lyophilizer (Freeze Dryer), Ultrasonicator/Sonicator, Ultra- and Mini- Centrifuge, Master sizer, Zeta sizer (including size and potential of particles in formulation), TLC (Thin Layer Chromatography), Photo stability cum humidity chamber, Spray dryer, pH meter, Chiller for low temperature reactions/solvent evaporation, Dissolution apparatus, Friabulator, Viscometer etc. Show less

Summer Internship

• Jul 2009 - Aug 2009

One month training in Production (Tablet, Liquid, Capsule, Powder) , Packaging and Quality Control) at U.P.D.P.L. in June 2009. Demonstration of Tablet, Syrup, Parenteral and ORS manufacturing, Punching machine, respected Packaging machines, Fluidized Bed Dryer, Dry and wet granulation and its proper evaluation as mentioned in Indian Pharmacopoeia at U.P.D.P.L., Lucknow. One month training in Production (Tablet, Liquid, Capsule, Powder) , Packaging and Quality Control) at U.P.D.P.L. in June 2009. Demonstration of Tablet, Syrup, Parenteral and ORS manufacturing, Punching machine, respected Packaging machines, Fluidized Bed Dryer, Dry and wet granulation and its proper evaluation as mentioned in Indian Pharmacopoeia at U.P.D.P.L., Lucknow.