VIPUL MISHRA
Contact: +77022236999 (KAZAKHSTAN)
E-Mail: mailto:vipul_onweb@yahoo.com
PASSPORT NO. H8221694
Seeking senior level positions in regulatory affairs in The pharmaceutical organization.
OVERVIEW
 An experienced Pharmaceutical Scientist with more than 6 years of research experience of Pharmaceutical
MNCs with a track record of success.
 Excellent in intellectual property with patent non-infringing processes development with
filling of ANDAs,
for highly regulated markets for all types of dosage forms in formulation as well as API USPTO, Espacenet,
WIPO, JPO, IPO, SIPO, Orange book ,IP evaluation for PARA-III & PARA-IV certifications and patent
invalidation report preparation , Review the literature alert patents/applications and respond to PDTs with
proper conclusions.
 Proficiency in Regulatory auditing of (WHO GENEVA,USFDA,MCC,MHRA,TGA,KFDA,ISO).
 An effective communicator with excellent relationship building
& interpersonal skills. Strong analytical,
problem solving & organisational abilities. Possess a flexible & detail oriented attitude.
ACADEMIC QUALIFICATION
DEGREE
YEAR
M.Sc. (Biotechnology.)
2007
B.Sc. (Biotechnology.)
INSTITUTE
BOARD/UNIVERSITY
PERCENTAGE
Barkatullah
Barkatullah ,,Bhopal
66%
2005
Barkatullah
Barkatullah,, Bhopal
60%
12th Biology ( PCBZ)
2002
C.G. Board
10th
2000
M.P. Board
Raipur
Bhopal
61%
66%
KEY SKILLS
Regulatory Development
Audits & Compliances
Regulatory Management
CTD & e-CTD Preparation
NDA/ ANDA Operations
Patent Programmed
Generics Programmed
Regulatory & Patent Operations
Regulatory Implementation
ORGANISATIONAL EXPERIENCE
Since inception in 1970
is amongst fastest growing Pharmaceutical company in ISRAEL
&
INTERNATIONAL European country , CIS MARKET, already setup in All of the art manufacturing
facilities in Belarus & Israel more than 52 Registered product , ensure to give the highest quality
Pharmaceutical products for the NATIONAL & INTERNATIONAL Market.
SK PHARMA GROUP / GARAN SK PHARMACEUTICAL LTD
SEP -2012
Head Quality & Regulatory Affairs
 I have a proven track record of developing ANDAs for highly regulated global markets.
 Development of ANDAs, for highly regulated markets for all forms of Oral solid Dosage formulations.
Bio-enhancement and Stability improvement of pharmaceutical formulations.
Preparations and Review of Product Development Reports, Validation Protocols, Bio-Study protocols and
other technical reports.

Planning and monitoring Bio-availability and Bio-Equivalence studies and coordinating for protocol
development and execution of studies.
 Managing multidisciplinary team of scientists.
Complete Project management-from conceptualization through product development, regulatory filling to
commercialization & Patent Drafting.
 Validation Protocols, Bio-study protocols and other technical reports. Identifying CRO/CMO with Coordinating
to Drug authorities.
 Leading team of 20 scientist with at least 50 active projects for different region and markets.
 Responsible for a wide array of complex technical work needed to develop a high quality product for
registration manufacturing, clinical studies and many more.

Responsible for Preparation of Dossier for formulation & Drug master file (DMF )for API for markets such
as USA, UK, European countries, Israel ,CIS, Hong Kong, China, and other semi-regulatory markets.
 Produce novel and value added formulations and processes and support patenting the new inventions.
 To manage product registration related documents such as Master Formula, Manufacturing Process, Critical
Process Parameters, along with Pharmacokinetic Pharmacodynamic and toxicological data.
 To assist in clinical study protocol preparation and monitor the study for assigned projects.
AARTI INDUSTRIES & SK PHARMA GROUP JOINT OPERATION
JULY-11 to AUG 2011
Position: Sr. Executive QA & RA
Key Responsibilities
 Handling of Customer’s Queries & Compliance ,Performed Regulatory International Audits
Independently.
 Regulatory Implementation of Quality Systems as per CTD Market Requirement .
 DMF Preparation, Reviewing of Open & Close Part (Technical Documents).
 Implementing schedules and carrying out periodic checks to ensure performance of various related
Regulatory work and maintaining requisite documents for the same.
 Handled The US & EU queries for All Regulatory Requirments
 Preparation of Regulatory Guidance, SOPs & Cleaning Validation Preparation of Validation Master plan ,smf
all Key Documents.
 Practicing quality standards with key emphasis on improving quality and

improvement Of regulatory drafting work as different market based products.
 All types of Formats Like Module 1 to 5 Prepared with BE/BA/Clinical report etc.
PIONEER PHARMA JORDAN AMMAN
JULY-10 TO JUNE 2011
Position: Supervisor QA
Key Responsibilities
 Handling and controlling all audits, asset care & allied activities.
 Worked as Regulatory & Quality development during my jobs and product trouble shooting on floor, GCC
based all requirements for dossier ACTD dossier Preparation .
 Maintaining of Defect BOOK & Planned Preventive maintenance, Using the GAMP good Automated
Practices. the base of ISPE ( International Society of Pharmaceutical Engineering).
 Daily communication (mails) Response & follow.
 Coordinating with Q.C., production & R&D department & provide them with technical support.
 Handling of Customer’s Queries & Compliance.
 Ensuring good working environment & management relations in the unit.
 Maintaining and improvising the cGMP work, in the plant.
 Delegating responsibility for supervision and Documentation of various regulatory.
 Overseeing training of all departments as well as driving & implementing small improvement project in the
company. Audit Report Preparations, Studying of Guidelines.
CORAL DRUGS PVT. LTD., DELHI
Role: International Auditor
1.4 Years (Feb 2009 to Jun2010
Position : Sr. executive QA
Key Responsibilities
 Preparation and handle audit authorities for WHO GMP AUDITS and related regulatory authorities of
other international agencies, such as, US-FDA- cGMPS, , etc.
 Liaison with all authorities during and start up of pharmaceuticals unit.
 Open part of DMF Preparation of , review and revision & their training and evaluation.
 Reviewed, revision and approval of documentation related equipment’s DQ,IQ,OQ and PQ, calibration
,process, sops, MFC,BMR, BPR ,SMF, validation, qualification, verification, stability, preventive maintenance
plan etc.
 Preparation of DMF/ CTD (Drug Master File / Common Technical Document )
 Preparation of TIP (Technical Information Package) , Reviewing of API Technology Transfer Documents.
 Reviewing of API Product Development Reports , Preparation of Annual Updates as per Schedule
 To prepared communication and approval of unit by FDA application for documentation for who GMP audits.
NESTOR Pharmaceutical Ltd
Faridabad HARYANA
1.2Years
Officer Q.A. & R.A(Nov2007 to Jan2009)
Key Responsibilities

Preparation and handle audit authorities for international agencies, such as TFDA ,MHRA
 Preparation of DMF/ CTD (Drug Master File / Common Technical Document )
 Preparation of TIP (Technical Information Package) , Reviewing of API Technology Transfer Documents.
 Reviewing of API Product Development Reports , Preparation of Annual Updates as per Schedule.
 Finalization of API Specifications, Change Controls, Deviations.
 Planning of all the Q.A. activities such as scheduling, implementation of preventive / corrective action plane
maintenance of utilities and plant machines.
 Preparation & Updation of Equipment Cleaning SOPs.
 Preparation & Comparison of Master Process Data sheet new Mfg Process
of New, Final & Intermediate
APIs , Handling of Deviation & Change Control.
 Preparation of Validation Reports for Final & intermediate , Retrospective Validation Reports , Concurrent
Validation Report , Annual Reports , Process Validation Reports ,Reviewed & Compliance of Process Data
Sheets,
IND-SWIFT LABORATORIES LIMITED EPIP PHASE-II BADDI (HIMACHAL PRADESH)
Formulation Q.A
1.6 Year ( May2006 to Oct 2007)
Key Responsibilities
 Good understanding of Quality systems of the organization & successfully ,
Co-ordinately woks in various International Vendors Audits like USFDA,MCC , MCA , WHO .& many
others Regulated & Non-Regulated Party Audits .
Consistently working in Review & Compilation of BMRs, BPRs, Q.C. Reports And Release of the batches ;
Preparation & Updation of SOPs and Good Documentation Practices .
Simultaneously works in Scheduling & Preparation of Class Room Training , Preparation of minutes &
Reporting to Unit Head & Online In process Checks, BMRs, BPRs, Reviewed.
 Regular GMP Round in the Tablet, Capsule & Injection Mfg. Areas.
 Validation Sampling plan preparation & online Sampling at different stages of Mfg of Tab. & Injection
 Cleaning Validation & R & D Batches Formulation
PROJECTS & TRAININGS UNDERTAKEN
Dr. reddy's Labs Ltd. (College Training Only)
Duration : 6 Months Training (May2004 to Oct2004)
Hyderabad