Regulatory affair specialist, clinical coordinator

PAYAL

SHAH

Address:

**** ********,

Medford,

MA,02155

E- mail:

actjo7@r.postjobfree.com

Phone:

(224)

409- 5973

- 1 -

PROFESSIONAL

SUMMARY:

Self- motivated,

innovative

Regulatory

Affairs

professional

with

Regulatory

Affair

Certification

(RAC)

• In- depth

knowledge

of

all

applicable

FDA,

EMA,

ICH- GxP

(GCP,

GMP,

GLP),

TMF

guidance

relating

to

Drugs,

Biologics and

Medical

Devices

• Strong

knowledge

of

510

(k),

PMA,

IND,

NDA

and

BLA

submissions

in

(e)CTD

format.

• Prepared

IRB

submissions,

Informed

Consent,

Protocol,

Reports,

SOP

and

Case

Report

Forms

(CRF)

• 5+ years

of

experience in conducting research for

preclinical

and clinical studies including continuous

assessment and

monitoring

of

study

results

as

per

regulatory

guidance

in

industry

and

academia

• Authored

7+

publications

in

peer- reviewed

journals.

Participated

in

state- of- the- art

preclinical,

clinical

research

and regulatory

affairs

oriented

global

conferences

and

workshops

in

USA

and

India

• Proven

interpersonal,

analytical

thinking,

organizational

and

time

management

skills PROFESSIONAL

EXPERIENCE:

Courses

completed

Nov

2013

–

Sep

2015

• ‘Design

and

interpretation

of

Clinical

Trail

and

Clinical

Problem

Solving’

• ‘Regulatory

cycle

for

Drug

and

Medical

device’

by

RAPS

• ‘Protecting

human

research

participants’

by

NIH

• ‘Fundamentals

of

Project

Planning

and

Management’

• ‘Building

an

Information

Risk

Management

Toolkit’

• ‘Data

management

in

clinical

Research’

• Appeared

for

GRE

and

TOEFL

• SAS

9

Certification

in

process

Clinical

Research

Coordinator,

Shivrath

Center

of

Excellence

in

Clinical

Research,

India

Sept

2011

to

Nov

2013

• Conducted

clinical

trials

for

oncology

(Drug)

and

cardiovascular

(Medical

device)

for

sponsor

with

strict

adherence to

GCP

guidelines

• Successfully coordinated and managed clinical trials, including communication with sponsors and regulatory authorities

• Responsible for data reporting and

management, collection of source documents, use and development of CRF, adverse

events

reporting,

filing

and

archiving

of

study

records,

and

resolution

of

data

queries

• Prepared and or completed regulatory related reports and IRB submissions. Maintained and organized study regulatory

binders,

and

entered

all

required

study

data

• Conducted

studies

according

to

ICH,

FDA,

EMA

guidelines Assistant

Professor,

Maliba

Pharmacy

College,

Uka

Tarsadia

University,

India

July

2009

to

Sept

2011

• Established an independent research program in the field of pharmacology (rheumatoid arthritis, ulcers, obesity) and clinical (stent compatibility and emesis in chemotherapy) following all regulatory requirements

with external funding

from

government

agency

• Supervised

graduate students for their

dissertation

on

obesity,

arthritis,

ulcer,

alzheimer’s

disease, cardiovascular stent

studies

which

were

appreciated

by

examiners

and

were

published

in

conferences

and

journals

• Worked

on

“Stem

cell

technology

for

non- invasive

cartilage

replacement”,

which

lead

to

positive

initial

output

and work

is

still

in

progress

• Designed

courses for

Clinical

Pharmacy,

Regulatory

Affairs,

Pharmacotherapeutics

and

Pharmacology for

graduate programs

Research

Trainee,

Jai

Research

Foundation,

India

July

2008

to

Feb

2009

• Prepared

protocol

and

reports

according

to

GLP,

OECD

and

FDA

guidelines

• Worked in preclinical research laboratory with research focused projects on wound healing, toxicity and rheumatoid

arthritis

• Developed

preclinical

models

for

characterization

of

drug

molecules

on

arthritis

and

its

treatment

options,

which

is still

used

as

reference

work

for

other

model

development

in

company PAYAL

SHAH

Address:

1078

Fellsway,

Medford,

MA,02155

E- mail:

actjo7@r.postjobfree.com

Phone:

(224)

409- 5973

- 2 -

• Contributed

in

protocol

designing,

report

preparations

and

regulatory

inspections

(GLP Research

Intern,

Trend

Pharma

Pvt.

Ltd,

India

May

2006

to

Sept

2007

• Successfully accomplished training and internship for the tablet

manufacturing

with a focus on drugs production and

quality

control

• Received

training

on

drug

dosage

forms,

quality

assurance

checks,

and

In

vitro

–

In

vivo

co- relationship EDUCATION:

Masters

of

Science

in

Regulatory

Affairs

for

Drugs,

Biologics,

and

Medical

Devices.

GPA

3.85/4.0

Sept

2015- present Northeastern

University,

Boston,

MA

Course

completed:

New

Drug

Development,

Medical

Device

Regulations,

Human

Experimentation,

Biologics development,

Regulatory

Affair

Strategy

and

Project

management Projects:

IND submission, SOP preparation, PMA submission, 510(k) submission, Regulatory strategy preparation for medical device

for

different

regulatory

agencies,

Biologics

submissions,

ICF

and

protocol

preparation Masters

of

Pharmacy,

Pharmacology.

GPA

3.56/4.0

June

2009 School

of

Pharmacy

and

Technological

Management

(SPTM),

Narsee

Monjee

Institute

of

Management

Studies

(NMIMS) University,

Mumbai,

Maharashtra,

India. Dissertation

Titles:

• “Efficacy and Toxicological Evaluation of Ethanolic Extract of Acorus calamus in Adjuvant- Induced Arthritic Wistar Rats”

• “Formulation

Development

and

Evaluation

of

Terbutaline

Sulphate

Rapid

Dissolving

Oral

Film” Bachelor

of

Pharmacy.

GPA

3.98/4.0

(Honor

student

–

Received

Gold

Medal)

June

2007 Maliba

Pharmacy

College,

Veer

Narmad

South

Gujarat

University,

Gujarat,

India. Thesis

Title:

“Stereochemistry:

Principles

and

Applications

in

Pharmaceutical

Chemistry” CERTIFICATES:

• Earned

“Regulatory

Affairs

Certification

(RAC)”

credentialed

by

Regulatory

Affairs

Professional

Society

(RAPS),

USA in

year

2015

• Awarded

“Protection

of

human

Research

Participation”

certification

by

NIH

in

year

2016

• Completed

“Fundamentals

of

Clinical

Trials”

course

organized

by

HarvardX

(www.edx.org/school/harvardx)

in

year 2014

• Earned

“Intellectual

Property

Right”

from

World

Intellectual

Property

Organization

in

year

2008 AWARDS

AND

MEMBERSHIPS:

• Recipient

of

the

“Best

Student

award”

from

“Indian

Drug

Manufacturer

Association”

in

2008

• Received

100%

travel

grant

from

Government

Agency

for

presenting

“Toxicity

study

of

Acorus

calamus”

in

Society of

Toxicology

49th

Annual

Meeting

and

ToxExpoTM

2010

at

Salt

Lake

City,

Utah,

USA

• Scored

94.59

percentile

in

GATE

(Graduate

Aptitude

Test

in

Engineering)

examination

in

year

2007

• Member,

Regulatory

Affairs

Professional

Society

(RAPS),

USA

(www.raps.org)

since

2013

• Active

member

of

Society

of

Toxicology

since

March

2009

• Life

time

member

of

Indian

Pharmaceutical

Association

since

2007 SKILLS:

• Documentation

and

laboratory

management

according

to

GLP,

GMP

and

GCP

requirements

• IND,

NDA,

510(K),

PMA

submission

process

and

documentations

• Microsoft

word,

Microsoft

excel,

Microsoft

PowerPoint,

outlook

and

Literature

search

• SAS

statistical

software,

PowerLab

instrument

operation

Contact this candidate