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Clinical Research Manager

September 07, 2018

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B.Pharm. & M. Sc. Clinical Research with *+ Yrs. Exp.



Personal profile:

Father’s Name: B. Duraisamy

Mother’s Name: D. Senthamarai

Date of Birth : 12.03.1986

Gender : Male

Nationality : Indian Marital

Status : Married

Passport : Yes

Permanent address: No: 70,

Mettu Street, Cheyyanandhal

Village, Polur Taluk,

Thiruvannamalai – DT Pin Code-

606 902.

Hands on experiences on

Publishing Tools:

eCTD Xpress

liquent Insight Manager

ISI Publisher

IST Toolbox

LORENZ eValidator

First doc (GDMS)


Extracurricular activities:

Participated “Research

proposal writing” in

Chettinad university at Jan


Participated national

seminar on “Clinical

Research – an Overview in

Chettinad University “at

Sep. 2009.

Participated in 2nd IAPST

Annual National


- 2008 held at Madras

Medical College,



Seeking a creative team environment in Regulatory Affairs that encourages continuous learning and creativity that provides exposure to new ideas and stimulates personal and professional growth on the platform of Pharma industry.

Employment Details:

Name of company Role Duration

Navitas Life Sciences Submission Manager (Sr.Assc.) Aug 2016-till Novo Nordisk Clinical Publisher May 2014-Jul22016

Take solutions (Pfizer) Regulatory associate April 2012-April 2014 Stedman Pharma Executive –Regulatory affairs Jul 2011 –March 2012 Auroville Healthcare Clinical research associate Sep 2010 – May 2011 Education Details:

2008-2010 M.Sc. in Clinical Research & Experimental Medicine, Chettinad University, Chennai.


2004-2008 Bachelors of Pharmacy, The Tamilnadu Dr. MGR Medical University Chennai.


2002-2004 HSC in St. Joseph’s Higher Sec. School, State board, Tamilnadu.


2001-2002 SSLC in St. Joseph’s Higher Sec. School, State board, Tamilnadu.


Job responsibilities as Submission Manager:

Deliver of submission packages to agreed schedule and technical specification for US, EU, CA

Advise and assist authors with the preparation of submission content and use of client document management systems and procedures

Maintain knowledge of relevant Regulatory Authority rules and client standards associated with submission format

Participate in the creation and implementation of Publishing working practices and procedures aimed at simplifying processes and increasing quality.

Coordinating submission documents with author, organize the documents as per HA requirements, provide guidance to Publisher, quality check and dispatch via HA portals (CESP, EMA &FDA/CA gateway) Job responsibilities as Clinical Publisher:

Responsible for compiling and publishing M5 dossiers for regulatory submissions

Word template creation, rendering, bookmarking, hyperlinking, table of contents creation, pagination, and formatting for esubmissions

Providing submission/document specific information to Publishers

Perform quality checks to published output for completeness and correctness in formatting and navigation for electronic submissions.

Compile, publish, QC check and validate the dossiers for regulatory submissions as per the validation criteria

Troubleshoot document publishing issues

Efficient in preparing and maintaining SOPs for Regulatory operations B.Pharm. & M. Sc. Clinical Research with 8+ Yrs. Exp. Job responsibilities as Regulatory associate:

Plan and publish following submissions (eCTD, Nees & paper) for US, EU & CA using View Point, ISI Publisher, eCTD Xpress, ISI Toolbox & Argus.

Original or Initial IND/NDA, Amendment/ Resubmission/Variations

General correspondence/ Briefing Package/ Ad promo Labeling/CMC/ Efficacy supplement

PADAR/PSUR/DSUR/Annual report IND safety report/SUSAR


Extracurricular activities:

Participated “Research

proposal writing” in

Chettinad university at Jan


Participated national

seminar on “Clinical

Research – an Overview in

Chettinad University “at

Sep. 2009.

Participated in 2nd IAPST

Annual National

Convention, 2008, Medical

College, Chennai.


Listening to Music

Playing games



HOD of Pharmacology,

Chettinad University, Chennai.


Ph. No:950*******


Principal Investigator, Azidus



Mail: Ph.

No: 988-***-****

Job responsibilities as Executive – Regulatory Affairs: Stedman Pharmaceutical Pvt. Ltd. is Chennai based Pharma industry exporting dugs to more than 25 countries. As a Executive my responsibilities are as follows:

Compilation of dossier & ensuring timely submission of dossiers to regulatory agency. (CTD, ACTD, ROW Countries, Other country specific

– Srilanka, Uganda, Zambia, Belies)

Review & evaluation of DMFs

Preparation of Labeling documents (USPI, SPC & Patient information leaflet)

Response to Regulatory queries and Safety reports/Notifications

Review of literature (Non clinical/Clinical data & Regulatory status)

Reviewing of Master Batch Records, Process Validation Protocols & Reports, Sampling protocols, stability study protocols & reports, Raw Material, API/Finished Product Specification and Test Methods Job responsibilities as Clinical Research Associate: Auroville healthcare R& D Pvt. Ltd. is Clinical Research Organization (CRO) in Chennai. As a CRO is contributing approximately 06 National & International clinical trials within 2 yrs. As a CRA my responsibilities were as follows:

Preparing Dossier for ASEAN, European & ROW Countries.

Communication with Regulatory Authorities & Ethics committee

(IEC/IRB) for getting approvals and Safety reports/notifications

Perform site selection, pre study, initiation, monitoring and close-out visits in accordance with our SOPs and good clinical practice.

Evaluate the quality and integrity of study related documents to the proper conduct of the protocol and adherence to applicable regulations.

QC checks the primary and secondary documents with source documents. Research projects:

Anxiolytic effect of homeopathic preparation of Pulsatilla nigricans in Swiss albino mice. Lakshmipathy Prabhu R, Ruckmani A, Venkatesan D, Madhusudhanan N, Pavithra R. Homeopathy. 2012 Jul;101(3):171-4. doi: 10.1016/j.homp.2012.05.003)

Extraction of volatile oil and evaluation of “Antibacterial, Antimicrobial effect” in Piper betel leaf.

Venkatesan. D



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