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. Sponsored links :
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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