Amit Kumar

M.Pharma (Pharmaceutics)
Delhi, Delhi, India
Pharmacist, English Language, Analytical Ability
About
I am AMIT KUMAR, M.Pharma (Pharmaceutics). I have 2 year’s experienced in Pharma Industry, currently working in Salve Pharmaceuticals (P) Ltd at New Delhi as DRA Executive in Drug Regulatory Affairs Department. I have completed my M. Pharma project work from PHARMCHEM PHARMACEUTICALS PVT. LTD (Quality control and R&D Department) was on topic “DESIGN AND DEVELOPMENT OF NOVAL COLON TARGETED DRUG DELIVERY SYSTEM OF ANTI RHEUMATIC DRUGS”.
Talents
Work Experience
DRA Executive
Salve Pharmaceuticals Pvt. Ltd
Full Time Feb-2016 To present 9 years 2 months
Responsibilities
  • ? Dossier preparation for registration of products with regulatory bodies of various countries & Responsible for Preparation of Dossier Approval Form.
    ? Actively involved in the work of Drug Office & NPPA (National Pharmaceutical Pricing Authority) like (COPP, PP, FSC, Submission of Fees & file put up).
    ? Active Co-ordination with F & D department, Production, QA, QC and Packaging department and for technical data required for preparation of dossier for various countries.
    ? Responsible for Compilation, Preparation & Review of Dossiers in CTD, ACTD formats & Short dossiers as per Regulatory Guidelines of Countries, CMC, DMF.
    ? Work for Registration of product Non-regulated market and ROW Countries
    ? Responsible for Review of Technical documents :
    (RM Specification, VMP, AMP, SMF, DMF, BMR, Analytical Method validation Protocol/report, Stability study protocol/ report. Process validation protocol and report.)
    ? Coordination with Plant Regulatory Department to Prepare and compilat
Achievements
  • Successfully Registered the Pharmaceutical Product in Myanmar, Vietnam, Philippians, Malaysia and Nepal Country by Submitting the dossier.
DRA Executive
Pharmachem
Full Time May-2014 To Feb-2016 1 year 9 months
Education
Master of Pharmacy, Pharmaceutics
Rameshwar Baleshwar CollegeLalit Narayan Mithila University
2013-2015 Score81%
Profile Snapshot
Amit is based out of Delhi & has studied Pharmaceutics, M.Pharma-Master of Pharmacy from Year 2013-2015 in RBC-Rameshwar Baleshwar College, Lalit Narayan Mithila University.
Amit Kumar is Skilled in Pharmacist, English Language, Analytical Ability and other talents.