Govindarajan yuvaraj-M.Pharmacy.

, DABT (GLP auditor)

Apply post- senior executive core regulatory or Global expansion
43, Sundaram Pillai Street, Purasawalkam, Chennai 7
Contact: 09952968059; Email: yuvas2010@gmail.com

Language Known-Telugu,tamil,English,hindi

<Recruiters Name>Yuvaraj
<Recruiters Designation>TOP management-QA regulatory Manager or senior executive
<Recruiters Company Name>Chromosoft techpark
<Recruiters Address>61,JH Road,Chennai,TN
<Recruiters City, State>Chennai

Dear Mr./Ms. <Surname>P.Govindarajan

I am submitting herewith my resume for your perusal and consideration for the post of <position vacant>in
your organization.
Regulatory manager-Pharmaceuticals/Biotech

To describe myself in a nutshell, I am systematic, organized and hardworking; ready to take up any challenge of
life abreast with the latest trends and a team player with excellent communication skills.

Review of my credentials will indicate that I am a qualified Research & Development Professional, seeking a
challenging job that would synergize my skills and knowledge with the objectives of the organization.

My core competencies include Research Management, Research Data Compilation, Team Management, Quality
/ Safety Management, Crisis Management, Project Coordination, Research Dissertation. Being a dedicated and
focused individual, I am determined to add value to the organization I work for, through my exceptional
knowledge and learning ability.

I have written 11 National/ 96 International articles; Handled Projects-34 Preclinical, 124 Clinical Trails
Projects (Business Management).

My basic objective is to hone in my skills for comprehensive personality development and be an epitome of
trust and reliability in the corporate world. My prime goal is to understand professional environment and
capitalize on opportunities.

I am confident of making visible contribution for the growth of the organization. I'd appreciate the chance to
meet with you in person to discuss as to how I could be a vital part of your organization.

Thanking you,

Yours sincerely,

Govindarajan yuvaraj
Govindarajan yuvaraj-M.Pharmacy.,
Old 43, Sundaram Pillai Street, Purasawalkam, Chennai 7
Contact: 09952968059; Email: yuvas2010@gmail.com

Pharmaceuticals MEDICAL/REGULATORY RESEARCH & DEVELOPMENT PROFESSIONAL
Seeking challenging assignments with an organization of repute across the industry

SUMMARY OF SKILLS

Technically astute & diligent professional with over 9 years of experience in GLP,WHO
GMP,ANVISA,TURKI-REGULATORY RESEARCH & DEVELOPMENT PROFESSIONAL
Possess in-depth knowledge & interest in Pharmacokinetics and Drug discovery and Drug development/
Medicinal chemistry; Pre-Clinical /Clinical research-Bio analytical department.
Well versed with monitoring daily activities for laboratory & project proposals, analyzing data &
critical evaluation of results and Writing scientific reports and papers based on observations and
experiments.
Written 11 National/ 96 International articles; Handled Projects-34 Preclinical, 124 Clinical Trails
Projects (Business Management).
Ability to manage human, financial and material resources towards the achievement of stated objectives, to
plan and manage work programs using sound decision-making skills.

Core Competencies
Research Management Research Data Compilation Team Management Quality / Safety Management
Crisis Management In vitro & In vivo Exposure Project Coordination Abreast of Market Competition
Research Dissertation

PROFESSIONAL EXPERIENCE
Asst Regulatory manager CRC group
Oct2005-Mar 2012
Trained to work in an ISO 17025 standard and UKAS recognized laboratory for scheduling the samples
workload, analyzing and reporting the results.
Trained to work in a laboratory with accordance to GLP and with environmental control.
Prepared stock solutions and working solutions for carrying out the experiments and maintaining and
checking the chemical stocks in the lab
Every day check of calibration standards record, instrument check record, Analytical quality control standard check and
also monthly maintenance of equipments and AQC charts.
Good knowledge on Method development and Validation.

Worked in chemistry department for doing the following methods
Determination of dissolved and total Mercury in waste water by ICP-MS using Perkin Elmer Elan DRC-e and ESI SC
0500-04 auto sampler.
Analysis of Suspended solids in different waste solutions using ACO, ABY and ABZ methods.
Analysis of total Kjeldahl nitrogen in waste waster
Analysis of pH, conductivity and turbidity for waste waters.





Worked in organic chemistry department for doing the following methods
Determination of unknown organic compounds in water by liquid-liquid extraction and detection by
GC with MS detection.
Analysis of substituted urea herbicides, Organo nitrogen and Organo phosphorous pesticides by direct injection and triple
quadruple LC/MS/MS
Determination of acid Herbicides, Benzoic acid herbicides, Benzonitrile herbicides, Pentachloro phenols
in water by liquid/liquid extraction, methylation and detection by GC-MS/MS
Determination of Trihalomethanes, Halogenated solvents, MTBE, TAME, BTEX compounds in water by head space gas
chromatography and mass spectroscopy detection.
Determination of 6 polycyclic aromatic compounds in raw and potable water by reverse phase HPLC.
Chromo soft InfoTech June 2012 to Till date
Modifying the existing assays or standardizing new assays as per the current literature and studying its
significance in the process of drug discovery and development.
Designing and planning primary and secondary screening cascade for drug discovery and implement
it for drug development.
Responsible for promoting and bringing in Preclinical, ADEMT BA/BE studies from major Pharma companies across the
globe. Developed website and company brochures as one of the promotion strategies.
Investigating the leads for preclinical development by reading published papers for the purpose of
Understanding the research area and perceiving where new contributions should be made.
Writing scientific reports and papers for peer-reviewed journals based on observations and experiments.
Participating in planning and designing of research protocol with principal Investigator. May propose and
implement new procedures relating to the projects when appropriate.
Presenting scientific data in conferences and meetings with collaborators of the project.
Responsible for the inflow and out flow of funds pertaining to CRO services; Performing as a key person to face the
auditors (USFDA, ANVISA); Applied for ISO 17025/15189 for the company.
Gathering useful information by reviewing research articles and review articles and by reviewing various sites
on internet.
Reviewing Research literature on various useful sites which give important information about the drug before and during
Method Development.
Performing all Exercises of Method Validation and writing Method SOPs.
Ensuring that documentation is done as per the departmental standard operating procedures (SOPs)
& regulatory guidelines.


Line Operator
Packing bread and buns and ensuring the packing is good and meets the quality standard
Controlling and monitoring the overall production and helping in minimizing the wastage of the raw materials
Ensuring HACCP is followed and met at all time

Skills I have good hands on knowledge of GCPs, ICH and FDA regulatory requirements and
experience with UV spectroscopy(UV1650PC SHIMADZU), HPLC ( Hewlett Packard
1100 HPLC with fluroscence detector), Direct injection and triple quadropole
LC/MS/MS( Agilent LC-QQQ 6410 system coupled to rapid resolution 1200 LC)
Liquid liquid extraction methylation and detection by GC-MS/MS(Agilent 7000A
GC-QQQ system interfaced with 7890 GC equipped with multimode inlet and 7693
autosampler), ICP-MS( Perkin Elmer Elan DRC-e and ESI SC-0500-04 autosampler),
NMR spectroscopy(BRUKER 400MHZ), IR spectroscopy, Scanning Electron
Microscopy(CAMBRIDGE S360), PXRD (BRUKER D
8
ADVANCE) and experience
with formulation of liquid, solid and semi-solid dosage forms using various techniques.



TECHNICAL PROFILE
Preparation, Review of Batch manufacturing records (BMR) and Batch Packing Records (BPR) along
with the Production department.
Has knowledge on ICH guidelines, Preformulation, Stability and Validation Studies
Module 1 Administrative and prescribing information. Module 2 Common Technical Document
Summaries. Module 3 - Quality (Process and analytical Validation for Drug Substance and Analytical
Method validation, Process Validation, Stability Studies, Microbial Limits Testing & Specifications for
the Drug Product. Module 4 Nonclinical Study report. Module 5 Clinical Study Reports,

Have used Mass hunter, Chem Station, LABS, LIMS, Instrument interfacing software for data processing and
results reported in accordance with both the requirements of ISO 17025 standard and
those of UKAS.

Personal Skills Excellent communication with confidence, Positive thinker, Problem solving skills,
handling dead line pressures, team worker, capability to work on own with less
supervision, Friendly.

Equipments Handled
LCMS-API-2000, 3200, 4000, Sciex Applied Bio-Systems, Canada UPLC Waters Acquity, USA HPLC
Waters Alliance-2695, USA HPLC, Shimadzu Prominence, Japan HPLC, Agilent 1100 and1200 series, USA
FT-IR spectrometer, Perkin Elmer, USA UV-Vis Spectrophotometer, Jasco, India Probe Sonicator Vibra
Cell, Sonics, USA Automatic nitrogen evaporator, Turbo Vap LV, Zymax corp. USA.

Accomplishments
Received Dr. Siddique Gold Medal for best article on Public Health entitled, Preliminary Report on the
Seroprevalence of Japanese Encephalitis among animals in Tamil Nadu published in the Indian Veterinary
Journal in 1999.
Received Dr. Krishnamoorthy Memorial Gold medal-best Short communication entitled Enzyme linked
Immunosorbent Assay for the detection of antibodies to Canine Adenovirus Type-1 published in the Indian
Veterinary journal in 1997.
Registered Pharmacist in The Tamil Nadu Pharmacy Council, Chennai (UG&PG).
Qualified GATE examination (M Pharma-Merit student).


EDUCATIONAL CREDENTIALS
M. Pharm
Post Graduation; 2004 JSS college of Pharmacy OOty
Dr. MGR medical University
B. Pharm; 1999-Dr.MGR medical University, Chennai, India
Professional Diploma in Drug Regulatory Affairs (PDDRA)CSI,chennai

Technical Proficiencies
Molecular Modeling Using SYBYL 6.7 (Tripos, USA) Comparative molecular field analysis (3-D QSAR)
using SYBYL 6.7 version Organic & semi Syntheses Invivo & invitro antioxidant, Heptaoprotective,
Antifertility anticancer Method development & validation of bio analytical methods using HPLC, UPLC and
LCMSMS Chromatographic principles with special emphasis on HPLC, UPLC and LC-MS/MS.

Computer Proficiencies
Microsoft office programs Chemistry software packages including the ISIS Draw, Chem LIMS (laboratory
information management systems) SYBYL 6.7 VERSION (TRIPOS- USA) COMPUTER AIED
MOLECULAR DESIGN(CAMD)

Training Attended
GLP-Basics of Good Laboratory Practice GCP-Good Clinical Practice

RESEARCH INTERESTS
Neurodegenerative diseases: Cerebral Ischemia, Parkinson disease
Oxidative stress induced changes in cell functioning
Endoplasmic reticulum stress induced changes in cell functioning
Diabetes Research and its associated complications like stroke, cardiomyopathy, neuropathy and
encephalopathy.
Neurotoxicity
Molecular biology
Apoptosis research
Signal transduction mechanisms
EXPERIMENTAL SKILLS
Knowledge of latest and updated regulatory guidelines from agencies like USFDA, ICH, CDSCO, OECD
as well as knowledge of subjects likes patents and intellectual property rights, etc.
Biostatistical analysis in relation to preclinical and clinical studies.
Expertise in handling of small laboratory animals and different surgical procedures.
Development of animal models of type 1 & type 2 diabetes, focal & global cerebral ischemia,
Parkinson's disease, neuropathic pain.
Behavioral experimentation related with memory impairment, hyperlocomotion, muscle coordination, grip
strength, analgesia etc.
Measurement of Cerebral blood flow & Nerve blood flow by Laser Doppler flowmetry
Safety pharmacological studies.
Molecular biology: Western blotting, Immunohistochemistry and ELISA, TUNEL Assay, DNA ladder and
Comet Assay/Histology and biochemical estimations
Handling and usage of various equipments like gaseous anesthesia system, powerlab system, Hargreaves
Planter instrument, Tail flick analgesiometer, Hot plate analgesiometer, stereotaxic apparatus, animal tracking
system (optovarimax), Morris water maze, Rota rod, non-invasive and invasive blood pressure recorder etc.

Date of Birth: 23
rd
April 1980
References: Dr.Vanitha Ram Chandra reddy managing Director, Chromosoft InfoTech
Contacts: 09094619345/any clarification mail:moks.ra@gmail.com