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[QUOTE=Guest-IJT;102954]Career Objective
To obtain a suitable position in pursuance of promising career where Hard work and sincerity recognized and appreciated.
Name : Miss. Sheetal Prakash Sawant.
Areas of Interest :
Industry expected :
Contact No :
Email address : Regulatory Affairs(REGULATED OR NON REGULATED MARKET)
RA/Pharmaceutical/Biopharm/CRO/Food/Medical Devices/
Diagnostic/Biology/Biotechnology/Cosmetics/Veterinary product/
Cosmetics/pharmaceutical consultancy.

Sheetal.rocks90 AT gmail.com
Experience Fresher
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 ICH-GCP Guidelines of safety, QUALITY, Efficacy and Multi-disciplinary 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 Home-made 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 AFFAIRS-QC/QA on 27thSEPT. 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:[/QUOTE]

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