Manager Assistant

CURRICULUM VITAE

Personal Details

Lakshmi Janakarajan Ph.D

Plot# 143, Second Street,

Kandaswamy Nagar,

Palavakkam,

Chennai- 600 041,

Tamil Nadu

Telephone Number: 91-(0-917*******; 959*******;

E-mail: ******************@*****.***

Nationality: Indian

Gender: Female

Marital Status: Single

Date of Birth: 03-05-1983

Current Position:

Assistant Manager, Regulatory at Take Solutions (7th May 2014 to Present)

for filing for EU- MRP/DCP/ National procedures for generics.

Last Position:

Assistant Manager, Regulatory Sciences at Biocon Limited, India (3rd Jan

2011 to 25th April 2014).

Regulatory experience:

. Part of a team that compiled and reviewed 2 INDs for clinical trials

for submission

. Compilation, review and submission of 8 DMFs, 4ASMFs for the regulated

markets of Europe, Canada and US ; eCTD conversion of compiled DMFs

. Submission of annual reports

. Regulatory query response for health authorities including EMA (4

deficiency responses), Swiss-medic (2 deficiency responses), health

Canada (1 deficiency response)

. Site accreditation application for JMAFF and site inspection

application for Brazil

. Variation filing and amendments - Compiled document for drug substance

portion for the variation application for customer; compiled dossier

amendments

. Compilation, review and submission of technical data packages for

customers; customer interactions and customer query response

. Compile statements for certifications and signing

. Scientific advise and regulatory requirements, review of quality,

regulatory and research/ development documents

. Variation classification, customer change notification and change

management

. Creation of database of all available clinical trails for an insulin

analog molecule

. Product development and quality, life cycle management, with limited

exposure to clinical and non-clinical study analysis and medical

device requirements

. Archival and folder maintenance

Regulatory Experience: 3.11 years

Techniques used in PhD/MSc project:

Cell and tissue culture (RBL-2H3, PBMCs, HeLa, Hep 2), developed cell based

assays, fluorimetry, fluorescence microscopic assays, chromatography (TLC,

HPLC, column),lipid raft isolation, cholesterol estimation, PCR, western

blot, blood cell isolation, protein isolation, DNA and plasmid isolation,

RNA isolation and basic molecular biology techniques. Trouble shot

analytical problems and bottle-necks during PhD.

Work Experience

1. Worked as Assistant Manager, Regulatory Sciencs at BIOCON, India,

January 2011- April 2014.

2. Worked in the capacity of Junior Research Fellow, in a collaborative

Project, "Drug- Discovery from Medicinal Plants", between Anna

University Chennai and Ranbaxy India Pvt. Ltd. During the period, Jan-

July, 2006

3. Worked as an Editorial Assistant for the Magazine, ADVANCED BIOTECH,

during the period June- October, 2005

Total Experience: 3.11 years in regulatory + 7 months in RnD + 4 months in

scientific publishing

Academic Background

Doctoral studies: Awarded PhD degree in Jan 2012.

Title of the Ph.D. Dissertation:

Mast Cell stabilizing properties of Steroidal Alkaloids isolated from

Solanum xanthocarpum: An assessment of their effects on early and late

phase allergic signals

(Jan 2006- October 2010)

University Where Registered and Research Pursued:

Centre for Biotechnology, Anna University Chennai

Fellowship awarded:

. Been awarded the Junior Research Fellowship from The Lady Tata

Memorial Trust Fund, 2006-2008

. Cleared CSIR LS (June 2006)

Other Academic Record

Sl. Name of the Name of the Institution University/ Percentag

No. Qualifying Board/ Year of e of

examination Passing Marks

Obtained

1 M.Sc (Molecular AL Mudaliar PG University of 74.658

Biology) Institute of Basic Madras,

Medical Sciences 2003-2005

2 B.Sc The Ethiraj College for University of 74.42

(Microbiology) Women, Chennai Madras,

2000-2003

3 Higher St. Dominic's Anglo Tamil Nadu 91.2

Secondary Indian Higher Secondary State Board,

Examination School, St. Thomas 1999-2000

(XII Standard) Mount, Chennai

4 Anglo Indian St. Dominic's Anglo Anglo-Indian 89.4

School Leaving Indian Higher Secondary Board,

Certificate School, St. Thomas 1997-1998

Exam (X Mount, Chennai

Standard)

Project Completed for M.Sc. Dissertation:

A case/control analysis of the ACE insertion/deletion polymorphism among

the essential hypertensives of Tamil Nadu

Other Academic Qualifications:

Completed a certificate course on Medical Laboratory Technology, conducted

by the Loyola Institute of Vocational Education, Loyola College, Chennai,

during the period July- December, 2002 and obtained the grade Outstanding;

also awarded the Second Prize for the best performance in the course.

Publications:

1. "Cyclosporin A stabilizes RBL-2H3 cell membrane via induction of WASP

phosphorylation and actin polymerization" Janakarajan L, Vinay Kumar

KS, Sarath Kumar B, Lakshmi BS International Journal of Integrative

Biology, 2010, 9 (2), 84-92.

2. "Molecular basis of the anti-inflammatory property exhibited by Cyclo-

pentano phenanthrenol isolated from Lippia nodiflora"Gayathri B,

Lakshmi J, Arun balakrishnan, Lakshmi BS Immunological

Investigations, 2010

3. "Biological evaluation of (3b)-STIGMAST-5-EN-3-OL as potent anti-

diabetic agent in regulating glucose transport using in vitro model"

S. Sujatha, S. Anand, K.N. Sangeetha, K. Shilpa, J. Lakshmi, A.

Balakrishnan, B.S. Lakshmi International Journal Of Diabetes

Mellitus, 2010

Conferences Attended

Various aspects of the work has been presented under the title "Stabilising

actin dynamics in RBL-2H3: An in Vitro model for anti-allergic drug

discovery" at two International conferences for scientific peer review.

1. The Molecular Medicine Conference, 2009, conducted at the IITM, Chennai

2. 5th World Congress on Cell and Molecular Biology, Nov 2nd-6th, 2009,

Indore

What am I good at?

1. Experience in working with regulated markets (EU and US)

2. Presentation skills and writing skills

3. Communication skills in English

4. Organization skills

5. Meeting deadlines

6. Analytical skills and problem solving

7. Regulatory experience in working with Biologics and Bio-similars

8. Scientific interpretation of regulations and scientific advise

9. Scientific knowledge and understanding (Microbiology, Molecular

Biology, Biotechnology)

About Me

I am a thinking individual; clear and decisive, open to others' ideas,

views and suggestions. The final decisions are products of my thought

process and hence my responsibility. Independence and freedom of thought

brings out the creativity in me and I live by the motto: "honesty is the

best policy".

Aims And Aspirations

In the next 5 years, I look forward to

1. A fulfilling career filled with exciting problem solving, client

interactions, contributing to clinching business deals, understanding

client needs and delivering.

2. A period of professional growth, encompassing work that stimulates the

mind to think, generates questions, forges ideas, culminating in solutions,

in an environment conducive to give free reign to scientific thought.

3. A simultaneous pursuing of MBA degree in Pharmaceutical Business

Development contributing to my learning curve

4. A period of continuous learning from every project and every hurdle

ultimately contributing to the growth of the organization and myself.

References

1. Dr. B. S. Lakshmi

Guide and Supervisor and Mentor for my Doctoral work

Associate Professor,

Centre for Biotechnology,

Anna University Chennai

Chennai, India.

Ph: 91-984*******

E-mail: *********@********.***

2. Dr. Guhan Jayaraman:

Doctoral Committee member and Mentor for Doctoral research

Professor

Dept. of Biotechnology

IIT, Madras

Chennai, India.

Ph: 91-44-225*****

E-mail: ******@****.**.**

3. Mrs. Hema Balasubramaniam

Deputy Manager- Regulatory Sciences

Biocon Limited

Ph: 997-***-****

4. Mrs. Jenis John Mathew

Deputy Manager - Quality Assurance (resigned)

Biocon Limited

Ph: 990-***-****

All the details I have provided are true to the best of my knowledge.

Lakshmi Janakarajan

20 Dec, 2014

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