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Name of the Candidate:[Private]
Name of the Post Applied:Drug Regulatory Affairs Executive
Job related skills / software:CTD Format Dossier Preparation, DMF Review
Category:Medical
Sub Category:Drug Regulatory Affairs Executive
Years of Experience:0 years
State:Maharashtra
Gender:Male
Salary Expected per Month(Rs):Negotiable
Highest Qualification attained:P.G.D. / PGD : Post Graduate Diploma
Major / Specialization:Drug Regulatory Affairs
Email Id:[Private]
 
Are you looking for job now?:No
Can the recruiter contact you?:No
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Career Objective :
To obtain a suitable position in pursuance of promising career where Hard work and sincerity recognized and appreciated.

Educational Qualifications :
Advanced Post Graduation Diploma in Drug Regulatory Affairs with 6 months internship in Perfect Pharma Consultant Pvt Ltd.
Basic Diploma in Clinical Management & Regulatory Affairs Haffkine Institute for Training Research & Testing. Passed in 2010.

Knowledge Having  :
Training in ICHGCP Guidelines of safety, QUALITY, Efficacy and Multidisciplinary with respect to Tripartite Region and Other Asian Countries.
Having knowledge of drug and cosmetic act, Y schedule, FDA, EMEA.
Clinical Research Phases.
International Regulatory Affairs for WHO, UKMHRA, USFDA, TGA.
Project on Committee for Proprietary Medicinal Product (CPMP) dossiers for marketing authorization of nisoldipine tablet
Bsc. Biotechnology  : Mumbai University : Mumbai college of Arts, Commerce and Sci, at Wadala. Passed in 2010.

Projects  :
Spoilage of Homemade Chatni sample  : Characteristics of organisms involved in spoilage of homemade Chatni sample were studied.
Diet plan for a High Blood pressure patient  : Nutrition and Diet plan for a High Blood pressure patient was prepared.
HSC passed in 2006 from S.R.P. junior college, Mumbai University with 55%.
SSC passed in 2004 from kumud vidya mandir, Mumbai University with 65%.

Workshop Attended  :
Attended and Participated 13th IDMA conference, 2010 held at Mumbai, Maharashtra.
Attended workshop on DRUG REGULATORY AFFAIRSQC/QA on 27thSEPT.
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2009, organized by Asian institute of health sciences, Mumbai.
Attended workshop on ICH GCP AND PHARMACOVIGILANCE on 4thOCT. 2009, organized by Asian institute of health sciences, Mumbai.
Attended workshop CDM AND MEDICAL WRITING on 11thOCT. 2009, organized by Asian institute of health sciences, Mumbai.

Summer Internship  :
Organization  : Milan Laboratories India Pvt Ltd, Kamothe, Panvel, Mumbai.
Period  : One and Half Months.
Subject  : To Understand Regulatory Affairs Profession and work on it.

Synopsis :
Review the documents used in QA/QC/Regulatory Affairs Viz. BMR, BPR, STP, ATP, SOP, APQR.PVR, MVP, Product Recall Protocol and Stability Protocol.
Regulatory Affairs Documents  : Review of DMF, MFR and Assisted in Preparation of CTD format Dossier.
Project guide  : Mrs.Sharvari Deshpande, Quality Operation Head.

Technical Qualifications :
MSCIT in Computers from Govt. Of India.
Internet operation.

Extra Curricular Activity  :
Participated in blood donation camp during Bsc. Biotech.
Attended various drawing and painting computations during school and college days.
Participated in various cultural events during bsc.biotech.

Personal Details :
Language Skills  :
English  : Read, Write,Speak
Marathi  : Read ,Write, Speak
Hindi  : Read, Write,Speak

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