MAULIK

PANCHAL

M.S.,

RAC

(Candidate)

*** *

Bonita

Avenue,

Apt

‘N’,

Claremont,

CA

-

91711

Phone:

(909)

542-

7579

e-

mail:

acej0w@r.postjobfree.com

PROFESSIONAL

SUMMARY

Driven

regulatory

affairs

professional

with

knowledge

in

biopharmaceutical

regulations,

ICH

&

FDA

Guidelines,

with

internship

experience

in

Regulatory

Affairs,

CMC,

Quality

Assurance

and

Manufacturing

with

robust

project

management

skills.

Quick

learner,

result-

oriented,

details-

driven

professional

seeking

a

full-

time

position

with

challenging

regulatory

and

business

roles

in

an

innovative

biopharmaceutical

company.

EDUCATION

&

CERTIFICATION

Regulatory

Affairs

Certificate,

US

(RAC)

Regulatory

Affairs

Professional

Society

(RAPS)

! Candidate

–

Spring

2014

University

of

Southern

California

(USC),

Los

Angeles,

CA

Masters

in

Regulatory

Sciences,

Class

of

2014

! Coursework:

Global

Regulations,

Regulations

of

Drugs

&

Biologics,

Medical

Product

Law,

Clinical

Trials

Design,

Quality

Systems

&

Standards

Keck

Graduate

Institute

of

Applied

Life

Sciences,

Claremont,

CA

Certification

in

Bioscience

Management,

Class

of

2012

! Coursework:

Pharmaceutical

Discovery

and

Development,

Market

Analysis

and

Assessment,

Bioscience

Strategy,

Molecular

Biotechnology

Rajiv

Gandhi

University

of

Health

Sciences,

Bengaluru,

India

Bachelors

in

Pharmacy,

Class

of

2010

! Coursework:

Advanced

Pharmaceutics

and

Drug

Delivery

Systems,

Pharmaceutical

Jurisprudence,

Medicinal

Chemistry,

Clinical

Pharmacology

PROFESSIONAL

INTERNSHIP

EXPERIENCE

CMC

Documentation

Coordinator

–

Puma

Biotechnology,

Inc.

Los

Angeles,

CA

Aug

2013

–

Dec

2013

! Reviewed

over

2000

CMC

documents

(Executed

Batch

Records,

Certificate

of

Analysis,

Certificate

of

Release

and

cGMP

Compliance)

from

Wyeth’s

and

Pfizer’s

technical

transfer

Packages

for

completeness

and

administrative

purposes

! Collaborated

with

vendors,

CMOs

and

cross-

functional

teams

of

Quality

and

Regulatory,

thus

fortifying

Puma’s

exhaustive

Document

Control

! Generated

‘Lot

Number

Genealogy’

for

backtracking

information

pertinent

to

product’s

and

comparators’

supply

chain

for

Clinical

Trials

! Executed

Gap

Analysis

by

reviewing

candidate’s

development

status,

helping

expedite

NDA

filing

goals

for

tactical

competitive

advantage

! Investigated

anomalies

in

tech

transfer

documents

relevant

to

Drug

Product,

Drug

Substance

and

Excipients

indispensible

for

NDA

submission

Regulatory

Coordinator

–

Puma

Biotechnology,

Inc.

Los

Angeles,

CA

Jun

2013

–

Aug

2013

! Reviewed

4000+

IND

documents

including

Cover

Letters,

Investigational

Brochures,

Protocols,

Amendments,

Queries/Responses,

Approvals,

IMPDs

and

correspondence

with

International

Health

Authorities

for

comprehensiveness

and

organizational

purposes

! Managed

vendors,

CROs

and

registered

global

submissions

within

Puma’s

central

Data

Management

repository

for

life

cycle

management

! Developed

Puma’s

Internal

Filing

System

by

tracking

and

archiving

Pfizer’s

international

product

registrations

for

Phase

II

and

Phase

III

studies

! Assessed

and

articulated

current

international

Health

Authorities’

specific

approval

requirements

across

Asia-

Pacific

and

European

Union

! Recommended

revisions

(implemented

post

hoc)

for

Naming

Conventions

–

SOPs

–

being

followed

for

archiving

FDA

Correspondences

Quality

Assurance

Assistant

–

Puma

Biotechnology,

Inc.

Los

Angeles,

CA

Jun

2013

–

Nov

2013

! Assisted

final

QA

review

team

to

facilitate

transitioning

training

records

from

paper

based

records

to

electronic

record

software

systems

! Assembled

complete

SOPs,

Training

Forms,

CAPA,

Work

Instructions,

Business

Policies,

etc.

into

physical

binders

for

training

purposes

Formulations

R&D

Associate

–

Ranbaxy

Laboratories,

R&D

Headquarters,

New

Delhi,

India

Sep

2010

-

May

2011

! Monitored

various

IPQC

(In

Process

Quality

Control)

activities

for

parenteral

unit

operations

in

sterile

plant

and

non-

sterile

solid

dosage

plant

! Maintained

Validation,

Calibration,

Out

of

Trends

and

Out

of

Specification

data

for

a

new

generation,

automated

freeze

dryer

–

Lyophilizer

! Articulated

solid

dosage,

bulk

level

characterization

test

outcomes

for

physicochemical

properties

of

excipients

for

oral

tablets

in

GLP

facility

GRADUATE

PROJECTS

AND

LEADERSHIP

Project

Lead

–

Global

Regulations

Strategy

Project,

University

of

Southern

California,

LA

Spring

2014

! Accomplished

a

comparative

study

of

combination

products’

regulations

in

EU;

BRIC

countries;

Australia-

New

Zealand

and

South

Korea

! Evaluated

competitive

landscape,

market

segments

&

regulatory

approval

challenges

for

CNS

biologics

in

Latin

American

countries

! Generated

a

regulatory

strategy

for

authorization

of

a

novel

anti-

diabetic

biologic

via

ANVISA

correspondence

and

KOL

interviews

! Determined

reimbursement,

price

control

and

trade

name

policies

influencing

the

approval

process

in

Brazil

-

Latin

America's

biggest

market

Generic

Regulatory

Planner

–

USFDA

and

EMA

Approval

Project,

University

of

Southern

California,

LA

Fall

2013

! Strategized

an

ANDA

of

a

hypothetical

generic

anti-

obesity

drug

(as

per

FDASIA

and

PDUFA

V)

for

USFDA

and

EMA

review

! Conducted

a

comparative

study

between

the

U.S.,

EU

and

Global

Generic

regulations

and

deduced

a

feasible

common

regulatory

strategy

! Identified

attributes

affecting

therapeutic

equivalence

and

suitability

petition

under

Section

505(j)

while

altering

RLD

(Reference

Listed

Drug)

Clinical

Trial

Protocol

Design

Project

–

Submission

Ready

Phase

IV

Protocol,

University

of

Southern

California,

LA

Spring

2012

! Authored

an

FDA

submission-

ready

Phase

IV

protocol

for

a

beta-

blocker

–

Carvedilol

–

for

Alzheimer’s

Disease

(AD)

as

its

new

indication

! Evaluated

competitors’

candidates

with

AD

as

its

new

indication

to

compare

and

correlate

phase

II

and

phase

III

design

trends

and

patterns

! Piloted

Power

Analysis

and

determined

sample

size

for

a

multi

center

clinical

trial

based

on

AD’s

primary

and

secondary

endpoints

! Drafted

Informed

Consent

Forms

(ICF)

for

Patients

and

Caregivers

in

compliance

with

USC’s

Instiatutional

Review

Board

Pre-

Market

Notification

–

510(k)

Application

Submission

Project,

University

of

Southern

California,

LA

Fall

2012

! Drafted

submission-

ready

510(k)

Application

document

for

FDA

approval

of

a

Class

I

device

–

Premixed

Dialysate

! Determined

substantially

equivalent

device

to

a

premixed

dialysate

for

CRRT

(Continuous

Renal

Replacement

Therapy)

! Exhibited

biocompatibility

compliance

with

ISO

10993

standards

and

labeled

the

device

compliant

with

21CFR

809.10

! Recommended

critical

design

changes

via

FMEA

matrix

as

a

Risk

Management

strategy,

in

accordance

with

ISO

14971:

2007

standards

Document

Control

Audit

Leader

–

QA

&

Compliance

Project,

University

of

Southern

California,

LA

Spring

2012

! Outlined

an

audit

plan

and

checklist

for

an

internationally

marketed

medical

device

in

accordance

with

ISO

13485

and

21

CFR

820

! Enlisted

specific

documents

required

to

assess

compliance

with

regulations

and

in-

house

SOPs

along

with

Validation

and

Qualification

system

Technical

Lead

–

In-

Vitro

Diagnostics

Project,

Keck

Graduate

Institute

of

Applied

Life

Sciences,

Claremont

Fall

2011

! Directed

a

regulatory

team

of

6

to

develop

a

fully

integrated,

frontend

medical

diagnostic

platform

to

Illumina’s

sequencing

device

–

MiSeq

! Defined

significant

and

non-

significant

risks

for

IDE

Risk

Classification

with

a

strategic

510(k)

submission

for

the

market

launch

TM

! Outlined

Process

Validation

Decision

Tree

for

companion

diagnostic

DakoCytomation

operating

together

along

with

MiSeq

! Resolved

device

complexity

for

Clinical

Laboratory

Improvement

Amendments

(CLIA)

waivers

and

summarized

software

and

assay

risks

INITIATIVES,

SKILLS

AND

INTERESTS

! Competencies:

Medical

Writing,

US

Pharmacopoeia,

21CFR,

ICH,

FDA,

ISO

guidelines,

Regulatory

Strategy,

Biostatistics,

clinicaltrials.gov

! Excellent

communication,

presentation

skills:

MS

Office,

MS

Outlook,

Adobe

Acrobat,

SharePoint,

Keynote,

SAS,

EDMS

! Organizing

Chair

of

‘RAC

Examination

Study

Group

-

2014’

at

USC’s

International

Center

for

Regulatory

Sciences

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