Divya Jaiswal

***F, Cloister road

Wilmington, Delaware 19809

USA

Phone- 678-***-****

E-mail: acbh3u@r.postjobfree.com

Objective: To obtain a challenging position that will utilize and further

develop my acquired skills and experience and lead to a

fulfilling career with the right organization.

Experience: Total 8 years of rich experience in pharmaceutical submission

management (Six years of rich experience as Drug regulatory writer and two

years as Project manager)

Area of Interest: Drug Regulatory Affairs, CMC, CTD, Project management,

Team management, Evidence based medicine,

Systematic review, Medical writing, Clinical Research,

Life Sciences Consultancy

Current Role: Worked as freelance Drug regulatory affairs and CMC

consultant from Sep 2011 to Dec 2012

Profile:

. Write and technically review to improve the quality of various

documents (manuscripts, CTDs, CMC sections (module 2 and 3) or entire

dossier/ DMF and protocols) as per the requirement of the client.

. Handling queries from FDA, EMEA, TPD and other regulatory authorities

. Medical Information support: Responsible for providing medical

information and scientific support for consumer healthcare products to

Physicians and Consumers

. Trainer and module developer in regulatory affairs and clinical

research. Trained medical professionals on clinical trials, Good

Clinical Practices (GCP), Case Report Form (CRF), Informed consent,

Electronic signature, Responsibility of stake holders, Investigational

new drug application (IND), Audit and inspections in clinical trial,

vendor selection, Clinical trial design .

Previous Experience: Worked as Astt. Manager - Health outcomes (Operations)

in HERON Health Private Limited from Jan 2010 to

Sept 2011.

Job Profile

. Creation and execution of technically review and improve the quality

of deliverables (manuscripts, CTDs, safety reports, and protocols)

prepared by team before passing to client. Act as a continuous

technical support to guide the team across projects in different

therapeutic areas

. Creation and execution of project work plans and revision as

appropriate to meet changing needs and requirements

. Effectively apply methodology and enforces project standards

. Prepare for engagement reviews and quality assurance procedures

. Minimize the exposure and risk on project

. Suggest and improve overall work processes and training programs

Previous Experience: Worked as Research Associate-II, Regulatory Affairs

(API) in Ind-swift Labs Ltd. Mohali from May 2007 to Jan

2010

Job Profile

. Review, writing and Submission of DMFs in international markets like US,

Europe and Canada as well as submission of applications to drug

Authority (DCG (I)) in India

. Review, Compilation and Submission of CEPs to EDQM

. Responding to the technical queries from Regulatory authorities and

customers to facilitate the in time registrations

. Filing of Amendments, Annual updates in the respective regions

. Participate in meetings, and training initiatives, project team meetings,

and maintain relationships with other departments, clients, and

regulatory agencies as necessary

. Coach and mentor on ICH guidelines, motivate and supervise project

team members and influence them to take positive action and

accountability for their assigned work

Previous Experience: Worked as Research Scientist, International Drug

Regulatory Affairs (Formulations) in Dabur Research Foundation (now

Fresenius kabi) Ghaziabad from Apr. 2006 to May 2007.

Job Profile

. Review, writing and Submission of ANDAs, MAAs, ANDSs in regulated markets

like US, Europe, Canada and Australia.

. Handling registration related queries or deficiencies from the respective

regulatory agencies.

. Filing of Amendments, Supplements and Variations in the respective

regions.

. Participation in the regulatory compliance audits at various sites.

. Tracking of the Regulatory GMP Question and Answers.

Previous Experience: Worked as Executive Drug Regulatory affairs in

Synmedic Laboratories

New Delhi from Sep-2005 to Apr-2006.

Job Profile

. Compilation & Review of Registration Dossiers for emerging market

(Vietnam, Combodia, Philippines)

. Preparation of Various regulatory Documents (Free sale certificate,

Certificate of pharmaceutical product)

Previous Experience: Worked as Apprentice (Documentation) in Ranbaxy

Laboratories Ltd. (now Daichi-sankyo), Dewas (M. P.) from Aug-2002 to Aug-

2003.

Job Profile

Review of Batch Production Records

. Writing & review of Standard Operating Procedures (SOPs)

Academic Credentials

Particulars Institute/ Year Class/Grade

University

M.Pharm S.G.S. I. T. S, 2006 First (73.54%)

(Medicinal & Indore/

Pharmaceutical R.G.P.V, Bhopal

Chemistry)

PGDBA (Operations S. C. D. L. Pune / 2005 First (66.18%

Management) Symbiosis Deemed /A)

University, Pune

B. Pharm S.G.S. I. T. S, 2002 First (69.73%)

Indore/

R.G.P.V, Bhopal

Higher Secondary V.G.H.S.S/ 1997 First (86%)

M.P.Board

High School V.G.H.S.S/ 1995 First (84.66%)

M.P.Board

Certifications

. Clinical Research training course from National Institutes of Health

(NIH), a part of the U.S. Department of Health and Human Services.

. General course on Intellectual Property Rights from World Intellectual

Property Organization, Geneva (89%)

. Certification in Clinical Research (CCCR) from S. C. H. C. Pune /

Symbiosis International University, Pune.

Research Papers Published in International Journals

. D. Jaiswal, C. Karthikeyan, and P. Trivedi; Rationalization of

Physicochemical Properties of AlkanoicAcid Derivatives towards Histone

Deacetylase Inhibition, Internet Electronic Journal of Molecular

Design 2006, 5, 13-26.

. D. Jaiswal, C. Karthikeyan, S. K. Shrivastava, and P. Trivedi ;QSAR

Modeling of Sulfonamide Inhibitors of Histone Deacetylase, Internet

Electronic Journal of Molecular Design 2006, 5, 345-354.

Computer Skills

. Operating Systems: Windows 98/2000, Windows XP, Windows7.

. Programs Known: C, Fortran, SAP entry

. Modeling Softwares: CS Chem Office (Chem draw), MOE.

. Statistical Softwares: SYSTAT & Valstat, Epi-info

. Basic Internet Skills & Literature searching

Achievements

. National Scholarship holder in 10th and 12th.

. Junior Research Fellowship from Dept. of Pharmacy, S.G.S.I.T.S.,

(A.I.C.T.E.) Indore. (Sep-

2003 to July-2005).

. GATE-02 with 87.63 percentile.

. Member of university journal's editorial board.

Membership

Asia consortium of ISPOR

American society for Pharmacy and Law

Declaration

I hereby declare that all the statements are true and correct to the best

of my knowledge and belief.

Date:

Place:

Divya Jaiswal

Contact this candidate