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Drug Regulatory Affairs Executive Resume Sample, Experience : 3 years

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Name of the Candidate:[Private]
Name of the Post Applied:Drug Regulatory Affairs Executive
Job related skills / software:Production, Formulation and Quality Assurance
Category:Medical
Sub Category:Drug Regulatory Affairs Executive
Years of Experience:3 years
State:Uttar Pradesh
Gender:Male
Salary Expected per Month(Rs):Negotiable
Highest Qualification attained:M.Pharm. : Master of Pharmacy
Major / Specialization:Pharmacology
Email Id:[Private]
 
Are you looking for job now?:No
Can the recruiter contact you?:No
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Work Experience (Since 06-July-2009) :
**    Presently working as Officer, Regulatory Affairs in Pfizer.
**    Previously worked with Worked Promed Research Centre and APCER Pharma India Limited.
Work Involved :
**    Involved in co-ordination with Plant, R&D and QA-QC Department for preparation and receiving of Documents.
**    Prepared dossier for different dosage forms such as tablet, eye drops, feed supplements and injections.
**    Involved in setting up specifications for different dosage forms.
**    Involved in preparation of documents.
**    Preparing, reviewing and submitting dossier for different countries (Asia-Pacific and African Countries).
**    Well versed with sending Samples to various countries and documentation required
**    Proficiency in communication with various country for timely and smoth registration
**    Understanding and well versed with Regulatory requirements of US, ICH guideline and EMEA guideline.
**    Prepared dossier as per CTD format for UK submission.
**    Prepared and filled dossier for European countries.
**    Involved in responding of queries asked by regulatory agencies (EMEA, Asia Pacific and African agencies).
**    Involved in Documentation of Dossier.
**    Preparing Dossier as per different country requirements and format.
**    Responding to queries asked by Regulatory Agency.
**    Renewals of dossiers as per regulatory requirement.
**    Review of documents.
**    Coordination with Production, Formulation and Quality Assurance departments for timely Regulatory submission.
**    Frequent visits to plant to collect documents and for better understanding of production.
PROJECTS AND SEMINARS :
M.Pharm II year Project at Advanced Drug Delivery Research (ADDR) at R&D, Panacea Biotec Ltd., Ambala-Chandigarh highway (10 months).
Industrial training at Dabur India Limited, during B.Pharm (After II year).
Attended Indian Pharmacy Council 2008, held at Delhi.
ACADEMIC CREDENTIALS :
**    M.
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Pharm-II from Jamia Hamdard, Hamdard University, New Delhi in 2009. Secured 72 %.
**    M. Pharm-I from Jamia Hamdard, Hamdard University, New Delhi in 2008. Secured 73 %.
**    Qualified GATE with 96.46 percentile in 2007.
**    B. Pharma. from Jamia Hamdard, Hamdard University, New Delhi in 2007. Secured 73.65 %.
**    12th from Greenway Modern School, C.B.S.E., Delhi in 2003. Secured 79.2 %.
**    10th from Nutan Vidya Mandir, C.B.S.E., Delhi in 2001. Secured 76 %.
**    IT Skills:  Well versed with MS Office, Internet Application etc.
Achievements :
**    First position in B.Pharm 1st  year (SFS).
**    First position in B.Pharm 2nd  year (SFS).
**    Second position in B.Pharm 3rd year (SFS).
**    Participated in Rx Champion Trophy (Cricket Tournament) and got the winner position.

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