cv_regulatory affairs
TRANSCRIPT
KAVITA YADAVAddress: 99, Nageshwar colony, Jetapur, Khargone (M.P.)Mobile No.: +91-9179381755Email:[email protected] OBJECTIVETo seek a position in pharmaceutical industry where, I can utilize my skills and academic knowledge to contribute actively in the progress of organization.EDUCATIONAL QUALIFICATION
Degree /Qualification Institute/School University/Board Year Remarks & Percentage
M. Pharm.(Industrial Pharmacy) S.G.S.I.T.S., Indore R.G.P.V., Bhopal 2014 7.42 SGPA
B. Pharm. IPS Academy, Indore R.G.P.V., Bhopal 2012 71.8%
HSC Govt. Girls H.S.School, Khargone M.P. Board 2006 82.4%
SSC Bhartiya Bal Mandir,Khargone M.P. Board 2004 77.6%
EXPERIENCEALPA LABORATORIES LIMITED, PIGDAMBER, INDOREPeriod: March 2015 to till dateDesignation: Officer Regulatory Affairs Job Profile: Preparation of ACTD dossiers for ASEAN Countries i.e. for Philippines, Vietnam and
Thailand. Preparation of Country Specific dossiers for LATAM Countries (i.e. Nicaragua, Dominican
Republic and Ecuador),CIS Countries (i.e. Kyrgystan and Turkemenistan) African Countries (i.e. Liberia, Nigeria, Sierra Leone, Georgia, Madagascar etc.) and Sri Lanka.
Preparation of FDA documents for registration of new product, License for new products (Proforma), CoPP data compilation and verification.
Review of Technical Data- Method of Analysis, Specifications, Process Validation Protocol, Process Validation Report, Product Development Report, Analytical Method Validation, Certificates of Analysis, Stability Protocol and Stability Report etc.
AREA OF INTERESTRegulatory Affairs ACADEMIC CREDENTIALSQualified GPAT-2012 with AIR-954 conducted by MSU, Baroda.
RESEARCH PROJECTS
M.Pharm research project on “Development of microsphere based sustained release ophthalmic formulation of acyclovir.”
B.Pharm project on “Algosomes.”PROFESSIONAL TRAININGUndergone 25 days training at Bombay Hospital Pharmacy, Indore, getting sound knowledge of prescription handling, dispensing of medicines, housekeeping, record management and store management.PRESENTATIONS AND SEMINARS Presented national level paper on “Patent Fights in Pharmaceutical Sectors in India” in IPC
2013 held at Amity University, Delhi NCR. Presented national level paper as a co author on “Impact of Mergers and Acquisitions of
Pharmaceutical Industry in Indian Scenario” in IPC 2013 held at Amity University, Noida, Delhi NCR.
Presented national level paper on “Recent Advances in Ocular Drug Delivery-An Overview” in Aayaam 2014 held at SGSITS, Indore.
Presented state level paper on “Ultrasonic Microbubbles: A Versatile tool for Targeted Drug Delivery System” in IPA M.P. State Branch Pharma Meet 2013.
Delivered seminar on “Patent Fights in Pharmaceutical Sectors in India” at Dept. of Pharmacy SGSITS, Indore for fulfillment of M. Pharm 1st year curriculum (June 2013).
Attended National level seminars conducted by Aurbindo College of pharmacy on “Bioethics and Recent Trends in Clinical Research”.
TECHNICAL EXPOSURE OF INSTRUMENTS/EQUIPMENTS Homogenizer (Kinematica) HPLC (Waters, Dionex) UV/Visible Spectrophotometer
(Shimadzu 1700 and 160 A) FTIR Spectrophotometer (Shimadzu) Multistation Rotary Punch Machine (20 station, Karnawati)
Dissolution Apparatus (Electrolab) Disintegration apparatus (Electrolab) Nano zetasizer(Microtrac) Lyophillizer (Virtis) Particle Size Analyzer (Malvern) Tapped density tester (Electrolab)
GUIDELINES STUDIED Rules codified under 21 CFR (cGMP, IND, NDA, ANDA etc.). Indian Patent Act and Rules. ICH guidelines (Stability of Drug Substance and Drug Products). WHO guidelines (Stability). Scale up and post approval changes guidelines (SUPAC). COMPUTER PROFICIENCY Patent search from various databases like USPTO. Proficiency in operating systems like Windows 07/08. Proficiency in MS-Office & Literature browsing.
EXTRA CURRICULAR ACTIVITIES Participated as volunteer in Aayam-2014 held at SGSITS, Indore.
Participated in drug distribution camp organized by COP, IPS Academy, Indore. Got 5th position in Marathon-2014 held at SGSITS, Indore.
PERSONAL PROFILEFather's name : Mr. Kailash YadavMother's name : Mrs. Kamla YadavFather’s occupation : Govt. job (M.P.E.B)Date of birth : 30/10/1988Marital status : Single Hobbies : Dancing and reading novels.Languages known : English and Hindi.Strengths : Punctuality, Adaptability, Positive Attitude and Quick Learning Ability.
REFERENCEDr. T. R. SainiProfessor and Head, Department of Pharmacy, S.G.S.I.T.S., 23 Park Road, Indore (M.P.)Contact No. +91 9424008654
Email- [email protected]
Mr. P. K. Soni Assistant Professor, Department of Pharmacy, S.G.S.I.T.S., 23 Park Road, Indore (M.P.) Contact No. +91 8878065156 [email protected]
DECLARATIONI declare that above mentioned details are completely true to best of my knowledge. Given an opportunity, I promise you to put my sincere efforts to rise to your expectations and become an asset to your esteemed organization.
Date:
Place: Indore Kavita Yadav