This document provides a summary of common regulatory affairs job interview questions and answers. It begins with defining regulatory affairs and its goals of protecting human health, ensuring drug safety and efficacy, and ensuring accurate product information. It then discusses the roles of regulatory affairs professionals in interacting with regulatory agencies, preparing submissions, and ensuring compliance. The rest of the document provides answers to common interview questions about regulatory submissions, guidelines, authorities, and key concepts and legislation related to drug approval.

1. Updated 2022
COMMON REGULATORY AFFAIRS
JOB INTERVIEW QUESTIONS WITH
ANSWERS By Pristyn Research
A quick Job interview short guide For Pharma and all
Life science jobseekers.
info.pristynresearch.com
www.pristynresearch.com
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Pristyn Resarch Solutions
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Regulatory Manager,
Pristyn Research Solutions
SHAHLINA KAHN
Prepared BY

3. For DRA Job Interview
with Answers
questions
01.
PAN India DRA companies
list alphabetically
Companies List
02.
What are the
contents?

4. section
DRA Job Interview
Questions and Answers

5. Regulatory Affairs (RA) in the Pharmaceutical industry is a profession that acts
as the interface between the pharmaceutical industry and Drug Regulatory
authorities worldwide. It mainly involves registering the drug products in their
respective countries before marketing.
What is regulatory affairs?
What are THE GOALS of RA
Professionals?
1
2
3
Protection of human health
Ensuring safety, efficacy
and quality of drugs
Ensuring appropriateness
and accuracy of product
information

6. WHAT ARE THE ROLES OF RA
PROFESSIONALS?
Act as a liaison with
regulatory agencies
Preparation of
organized and
scientifically valid NDA,
ANDA, INDA, MAA, and
DMF submissions
Ensure adherence
and compliance with
all the applicable
cGMP, ICH, GCP, and
GLP guidelines
Providing expertise
and regulatory
intelligence in
translating regulatory
requirements into
practical work plans
Advising the companies
on regulatory aspects
and climate that would
affect their proposed
activities

7. Suppliers
Clinical study
Product
Development
Marketing
Project
Management
Licenses
Quality
Assurance and
Quality Control
Product
Manufacturing
Licensors
Customers
REGULATORY AUTHORITIES
WHAT IS SPECTRUM OF REGULATORY
AFFAIRES ?

8. What ARE DIFFERENT TYPES OF SUBMISSIONS
REQUIRED FOR DRUG APPROVAL PROCESS ?
INDA Investigational New Drug (IND) Application
NDA New Drug Application
ANDA Abbreviated New Drug Application
DMF Drug Master File
MAA Marketing Authorization Application

9. What is an Investigational New Drug
application (INDA)?
It is an application filed with the FDA to get approval for legally testing an
experimental drug on human subjects in the USA.
WHAT IS A NEW DRUG APPLICATION (NDA)?
• “It is an application filed with the FDA to market a new Pharmaceutical for sale in
the USA.”
• The NDA is the vehicle through which drug sponsors formally propose that the FDA
approve a new pharmaceutical for sale and marketing in the US. The data
gathered during the animal studies and human clinical trials of an investigational
drug become part of the NDA.

10. What is an Abbreviated New Drug
Application (ANDA)?
• “It is an application for the approval of Generic Drugs “.
• It is an application filed with FDA for a US generic drug approval for an existing
licensed medication or approved drug.
What is a Marketing Authorization
Application, and how many days it is valid
for?
It is an application filed with the relevant
authority in Europe (typically, the UK's MHRA
or the EMA's Committee for Medicinal
Products for Human Use (CHMP)) to market a
drug or medicine.
Validity: In most countries, it is valid for 5
years, and one should apply for renewal.

11. It is submitted to FDA to provide confidential
information
Its submission is not required by law or regulations
It is neither approved nor disapproved
It is provided for in the 21 CFR (Code of Federal
Regulations) 314. 420
It is not required when the applicant references its
information
A Drug Master File (DMF) is a submission to the Food and Drug Administration
(FDA) that may be used to provide confidential detailed information about
facilities, processes, or articles used in the manufacturing, processing, packaging,
and storing of one or more human drugs.
What is DMF?
Essential aspects of DMF?
It is filed with FDA to support NDA, IND, ANDA, another DMF or amendments and
supplements to any of these

12. TYPES OF DMF
01
TYPE I
Manufacturing Site,
Facilities, Operating
Procedures, and
Personnel (No longer
accepted by FDA)
TYPE III
Packaging Material
03
02 04
TYPE II
Drug Substance, Drug
Substance Intermediate,
and Material Used in Their
Preparation, or Drug Product
TYPE IV
Excipient, Colorant, Flavor,
Essence, or Material Used
in Their Preparation
05
TYPE V
FDA Accepted
Reference
Information (FDA
discourages its use)

13. What is Orange Book?
“It is the commonly used name for the book "Approved Drug Products with
Therapeutic Equivalence Evaluations" published by USFDA".
It contains the list of drug products approved based on safety and
effectiveness by the Food and Drug Administration (FDA) under the Federal
Food, Drug, and Cosmetic Act.
What is a Generic Drug Product?
A generic drug product is the one that is comparable to an innovator drug
product in dosage form, strength, route of administration, quality, performance
characteristics and intended use.

14. What is a 505 (b)(2) application?
• 505 (B)(2) application is a type of NDA for which one or more
investigations relied on by the applicant for approval were not conducted
by/for the applicant and for which the applicant has not obtained a right
of reference.
What kind of application can be
SUBMITTED as a 505(b)(2) application?
• New chemical entity (NCE)/new molecular entity (NME)
• Changes to previously approved drugs
Application

15. Pristyn
Research®
DRA Job Interview
Questions and
Answers
1
Drug already
marketed, but not
approved NDA
3
New
indication
5
New
manufacturer
7
New
combination
2
4
6
8
New ester, new
salt, other
derivative
New molecular
entity (NME)
OTC (over-
the-counter)
switch
New
formulation
What are the chemical
classification codes for
NDA?

16. How DOES NDA differ from 505 (b)(2)
application ?
New drug application
(NDA)
APPLICATION
505 (b) (2)
All investigations relied on by the
applicant for approval were conducted
by/for the applicant and for which
applicant has right of reference
One or more investigations relied on
by the applicant for approval were
not conducted by/for the applicant
and for which the applicant has not
obtained a right of reference.
They generally filed for newly invented
pharmaceuticals.
They generally filed for new dosage
forms, routes of administration, and
indications for all already approved
pharmaceuticals.
NOTE: 505 (b)(2) application is a type of NDA

17. What is ICH?
International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH): is a project that brings
together the regulatory authorities of Europe, Japan and the United States and
experts from the pharmaceutical industry in the three regions to discuss scientific
and technical aspects of pharmaceutical product registration.
What are the ICH guidelines to be referred
for PREPARING registration dossiers?
• M4 Guideline
• M4Q Guideline
• M4S Guideline
• M4E Guideline

18. Name the core regulatory bodies
India: IDA Indian Drug
Administration previously known as
Central Drugs Standard Control
Organization (CDSCO)
CDSCO
Australia: Therapeutic
Goods Administration
TGA
USA: United States Food
and drug administration
USFDA
UK: Medicines and Healthcare
Products Regulatory Agency
MHRA
Europe: European
Medicines Agency
EMA
Canada- Health
Canada
HC
China - National Medical Products
Administration (NMPA)
NMPA
Japan: Ministry of Health,
Labour and Welfare
MHLW
ANVISA
Agência Nacional de’
Vigilância Sanitária –Brazil
(National Health
Surveillance Agency)

19. What is an ASMF?
• An active substance master file is
submitted to EMA, MHRA or any other Drug
Regulatory Authority in Europe to provide
confidential intellectual property or
'know-how' of the active substance
manufacturer .
• Simply put, "It is a submission made to
European Drug regulatory agencies on
the confidential information of Active
Substance or Active Pharmaceutical
Ingredient (API)".
What is the difference between DMF and
ASMF (concerning submission)?
• ASMF is submitted as Applicant’s Part (Open Part) and Restricted Part (Closed Part)
• There isn’t any differentiation of DMFs into parts.

20. What are the types of active substances
for which ASMFs are submitted?
A
B
C
New active substances
Existing active substances not
included in the European
Pharmacopoeia.
Pharmacopoeial active substances
included in the European
pharmacopoeia

21. What ARE CTD and ITS modules?
• The Common Technical Document (CTD) is a set of specifications for the
application dossier for the registration of Medicines and is designed to be used
across Europe, Japan and the United States.
• Quality, Safety and Efficacy information is assembled in a standard
format through CTD . The CTD is maintained by the ICH.
• CTD format for submission of drug registration applications/dossiers is widely
accepted by regulatory authorities of other countries like, Canada, Australia etc.
Module 4
Nonclinical Study
Reports (toxicology
studies)
Module 5
Clinical Study
Reports (clinical
studies)
Module 3
Module 2
It summaries
Overview and
summary of
modules 3 to 5
Module 1
Administrative
information and
prescribing
information
Quality
1 2 3
4 5

22. What are the examples of changes to
approved drug products for which
505(b)(2) application should be submitted ?
Strength and
dosage form
Formulation
and API
Route of
administration
and dosing
New
combination
Product and
its indication
Naturally
derived/
recombinant
API
From
prescription
indication to
OTC
Bioequivalence

23. What is Hatch-Waxman act?
• It is the popular name for Drug Price Competition and Patent Term Restoration
Act, 1984.
• It is considered the landmark legislation that established the modern generic
drug system in the USA.
• Hatch-Waxman's amendment of the federal food, drug and cosmetics act
established the process by which would-be marketers of generic drugs can file
an Abbreviated New Drug Application (ANDA) to seek FDA approval of generic
drugs. Paragraph IV of the act allows 180-day exclusivity to companies that are
the "first-to-file "an ANDA against holders of patents for branded counterparts.
• Simply put, "Hatch-Waxman act is the amendment to Federal, Food, Drug and
Cosmetics act which established the modern system of approval of generics".

24. What are the patent certifications
under the Hatch-Waxman act?
As per the Hatch and Waxman act, generic drug and 505 (b) (2) applicants
should include certifications in their applications for each patent listed in the
“Orange Book” for the innovator drug. This certification must state one of the
following:
1. The required patent information relating to such patent has not been filed
(Para I certification);
2. The Patent has expired (Para II certification);
3. The Patent will expire on a particular date (Para III certification); or
4. The Patent is invalid or will not be infringed by the drug for which approval
being sought(Para IV certification).
A certification under paragraph I or II permits the ANDA to be approved
immediately if it is otherwise eligible. A certification under paragraph III
indicates that the ANDA may be approved when the patent expires.

25. What is meant by 180-dayS exclusivity?
The Hatch-Waxman Amendments provide an incentive of 180 days of market
exclusivity to the “first” generic applicant who challenges a listed patent by filing
a paragraph IV certification and thereby runs the risk of defending a patent
infringement suit.
180-Day Exclusivity could be granted to more than one applicant. A recent
example is 180-day exclusivity was granted to Ranbaxy and Watson Laboratories
for marketing a generic version of Lipitor ( Atorvastatin calcium).

26. What are the procedures for Approval of
Drug in EU?
Centralized Procedure (CP)
Decentralized Procedure (DCP)
Mutual Recognition Procedure (MRP)
National Procedure (NP)

27. What is the Full form of abbreviation,
CEP?
• Certificate of Suitability to the monographs of the European Pharmacopoeia.
• It is also informally referred to as the Certificate of Suitability (COS).
What is a CEP?
It is the certificate issued by the Certification of Substances Division of the
European Directorate for the Quality of Medicines (EDQM) when the manufacturer
of a substance provides proof that the quality is suitably controlled by the
relevant monographs of the European Pharmacopoeia.

28. What is a dossier?
A Pharmaceutical dossier is a collection of detailed information about a
particular person or substance required for submission to the regulatory
authority to get licence.
What are medical device regulatory
affairs?
Regulatory affair is a profession developed from the desire of governments to
protect public health by controlling the safety and efficacy of products in areas
including pharmaceuticals, veterinary medicines, medical devices, pesticides,
agrochemicals, cosmetics and complementary medicines and by the companies.
What does a regulatory framework mean?
Regulatory Framework means any laws, regulations, decrees, and policies
officially developed and approved by the government to regulate the SOLID
WASTE generation, collection, transport, recycling, reuse, treatment and
disposal.

29. What is a regulatory
process?
The Regulatory Process. What is a regulation?
Regulations, or rules, are a primary vehicle
with which agencies implement specific laws
and general agency objectives. They are
specific standards or instructions concerning
what can or can not be done by an individual,
business, and other organizations.
What are regulatory standards?
Regulatory standards are laws, rules, regulations, regulatory authority
advisory opinions or orders applicable to manufacturing, marketing, sales,
reimbursement and pricing of any Products.

30. What are the statutory and regulatory
requirements?
Both statutory requirements and regulatory requirements are those requirements
that are required by laws.
Statutory Requirements - Laws passed by a state and central government.
Regulatory Requirements - A rule issued by a regulatory body appointed by a state
and central government Standard - Documented procedure whose intention is to
harmonize actions or processes within a specific discipline or activity.
What is the purpose of regulatory
compliance?
Regulatory compliance is an organization's adherence to laws, regulations,
guidelines and specifications relevant to its business processes. Violations of
regulatory compliance often result in legal punishment, including federal fines.

31. What is a regulated drug?
A regulated drug is researched, manufactured, distributed, and administered
under the supervision of regulatory authorities. While all the different types of
regulated drugs vary, they have one overarching thing in common: they're
controlled by the Controlled Substance Act (CSA).
What are the Examples of Regulated
Drugs ?
The CSA categorizes its controlled substances into five schedules. Drugs in
schedule five have the least potential for abuse, and those in schedule one have
the most dependence risk.
Here are some examples of regulated drugs in each of the five schedules:
Schedule I: Marijuana & LSD
Schedule II: Adderall & Cocaine
Schedule III: Testosterone & Ketamine
Schedule IV: Xanax & Valium
Schedule V: Some cough medicines & Lyrica

32. What is difference between Regulated vs.
Prohibited drugs?
The main difference between regulated and prohibited drugs is that the
government regulates one type and the other is not. They may also be ranked
differently in terms of addictiveness.
However, regulated and prohibited drugs can be hazardous and harmful to
several areas of health.
What Are “Prohibited Drugs?”
Prohibited drugs are pretty much off-limits in the eye of the law. This means they
can't be legally bought or sold in The United States. Prohibited drugs can be
hazardous and are not medically monitored. These types of substances may
include heroin or methamphetamine.

33. Which Products Need FDA Approval?
❑ Human and animal drugs.
❑ Medical biologics.
❑ Medical devices.
❑ Food (including animal food)
❑ Tobacco products.
❑ Cosmetics.
❑ Electronic products that emit radiation.
WHAT IS CFR?
The Code of Federal Regulations (CFR) is a
codification of the general and permanent rules
published in the Federal Register by departments
and agencies of the federal government. Title of 21
CFR is reserved for the Food and drug
administration.

34. Who controls cfr?
The CFR is divided into 50 titles representing broad areas subject to federal
regulation. The CFR annual edition codifies the general and permanent rules
published by the Office of the federal register (part of the national archives and
records administration) and the government publishing office.
What does 510k mean?
510(K) is a premarket submission made to FDA to
demonstrate that the device to be marketed is as
safe and effective, that is, substantially
equivalent, to a legally marketed device (section
513 (i)(1)(A) FD&C Act) that is not subject to
premarket approval.

35. What are the 3 main principles of GCP?
The three basic ethical principles of equal importance, namely respect for persons,
beneficence, and justice, permeate all other GCP principles. Human research
should be scientifically justified and described in a clear, detailed protocol.
Do natural products need FDA approval?
The law does not require cosmetic products and ingredients, except for colour
additives, to be approved by FDA before they go on the market. The individual is
legally responsible for ensuring the cosmetics are safe and properly labelled, in
compliance with all the laws and regulations that apply to them.

36. WHAT IS cmc in regulatory affairs?
Chemistry, Manufacturing and Controls (CMC) of a medicinal product is the body
of information that defines not only the manufacturing process itself but also the
quality control release testing, specifications and stability of the product, together
with the manufacturing facility and all of its support utilities, including their design,
qualification, operation and maintenance.
CMC regulatory affairs and compliance is seen as a process of governance which
ensures CMC practices are carried out in agreement with regulatory agencies'
requirements and expectations.
Since such requirements and expectations change with time, a function of CMC
regulatory compliance is to ensure that all CMC practices are updated
accordingly.

37. What is the Pharma ROW market?
United States (US) and the EU are the biggest and the most potential markets for
the world and are categorized under the regulated markets, whereas the ROW
(Rest of the World) the market includes all the emerging markets like Brazil
(LATAM), Tanzania (Africa), Russia (CIS), Hong Kong (ASIA), etc.
What is the difference between CTD and
Actd?
The ACTD consists of Parts I to IV, which have subsections A to F, whereas ICH-
CTD has 5 Modules with numbered subsections. The administrative data of Part I
is part of ACTD, whereas Module 1 of ICH-CTD is purely country-specific.

38. What are regulatory affairs in the
pharmaceutical industry?
Regulatory Affairs (RA), also called Government Affairs, is a profession within
regulated industries, such as pharmaceuticals, medical devices, energy, and
banking. Pharmaceutical companies use all the data accumulated during
the discovery and development stages to register the drug and thus market
the drug.

39. What are the recently approved new
Drugs by FDA?
Drug Name
Active
Ingredient
Approval
Date
FDA-approved use on
approval date
Adbry
Tralokinumab-
ldrm
12/27/2021
To treat moderate-to-severe
atopic dermatitis
Vyvgart
Efgartigimod alfa-
fcab
12/17/2021
To treat generalized
myasthenia gravis
Tezspire
Tezepelumab-
ekko
12/17/2021
To treat severe asthma as an
add-on maintenance
therapy
Cytalux Pafolacianine 11/29/2021
To help identify ovarian
cancer lesions
Voxzogo Vosoritide 11/19/2021
To improve growth in children
five years of age and older
with achondroplasia and
open epiphyses

40. Well known Drug Regulatory Agencies
across the world-
Sr. No. Country /Region Regulatory Agency
1
United States of
America
United States Food and Drug
Administration (USFDA).
2 United Kingdom
Medicines and Healthcare products
Regulatory Agency (MHRA).
3 European Union European Medicines Agency (EMA).
4 European Union
European Directorate for the Quality of
Medicines (EDQM).
5 Australia
Therapeutic Goods
Administration (TGA).
6 Japan
Pharmaceutical and Medical Devices
Agency (PMDA).
7 Singapore Health Sciences Authority (HSA).

41. Sr. No.
Country
/Region
Regulatory Agency
8 Canada
Therapeutic Products Directorate (TPD) in Health
Product and food branch (HPFB) of Health
Canada (HC).
9 France
Agence Francaise de Securite Sanitaire des
Produits de Sante (AFSSAPS).
10 Germany
Bundesinstitut für Arzneimittel und
Medizinprodukte, (BfArM).
11 India
Drugs Controller General of India (DCGI) who
heads Central Drugs Standard Control
Organization (CDSCO).
12 Switzerland
Swiss Agency for Therapeutic
Products (SWISSMEDIC).
13 Brazil
Agencies National de Vigilance
Sanitaria (ANVISA).
14 Singapore Health Sciences Authority (HSA).
15 New Zealand
New Zealand Medicines and Medical Devices
Safety Authority (MEDSAFE).

42. Abbreviation Full Form
NDA New Drug Application
ANDA Abbreviated New Drug application
IND Investigational New Drug Application
DMF Drug Master file
ASMF Active Substance Master File
MAA Marketing Authorization Application
CEP
Certificate of Suitability to the monographs of the
European Pharmacopoeia
ICH
The International Conference on Harmonization of
technical requirements for registration of Pharmaceuticals
for human use.
CTD
Common technical document for the registration of
pharmaceuticals for human use.
AP Applicant’s Part
RP Restricted Part
OP Open Part

43. Abbreviation Full Form
CP Closed Part
NME New Molecular Entity
NCE New Chemical Entity
SmPC Summary of Product Characteristics
PL Packaging Leaflet
RMS Reference Member State
CMS Concerned Member State
CHMP The Committee for Medicinal Products for Human Use
CPMP Committee for Proprietary Medicinal Products
CVMP Committee For Medicinal Products For Veterinary Use
SUPAC Scale-up and post approval changes
BACPAC Bulk Active Chemicals Post approval Changes
GCP Good clinical Practice
GLP Good Laboratory Practice

44. Companies
List
PAN India DRA companies list
alphabetically
02

45. Companies List
ABBOTTS CIPLA
I 3 GLOBAL DRUG
SAFETY
labcorp
OMNICARECL
INICAL
RESEARCH
SUN PHARMA
ACCENTURE
COGNIZANT I GATE PATNI
COMPUTERS
LAURUS LABS PARAXEL SYMOGEN
AJANTA
PHARMA
DIAGNOSEAR
CH
ICON
MAHINDRA
SATYAMBSG
PIRAMAL
Syneos
HealtH
ALEMBIC DR REDDY’S iMEDGlobal, MAKROCARE PPD
Syngene
Internation
al
APC PHARMA.
ECRON
ACUNOVA
IMS HEALTH MANKIND
QUANTUM
SOLUTIONS
TAKE
SOLUTIONS
APCER EMCURE INC RESEARCH MEDHIMALAYAS QUINTILES TCS
ASTRAZENECA FDC
Infocorp Soft
Solutions
MEDPACE.
SCIFORMIX
RATIOPHARM
THOMSON
REUTERS
AUROBINDO
FORTIS
HEALTH CARE
INVENTIVE MICRO LABS RX MD USV LIMITED
BESTOCHEM G7 INFOTECH
IPCA
LABORATORIES
MSD (MERCK)
SANTHA
BIOTECH
VIMTA LABS
BIOCAD GENPACT IPLEX
NEKTAR
THERAPEUTICS
SCIFORMIX. WIPRO
BIOCON GRANULES JUBILIANT-BIOSYS
NORWICH
CLINICAL SERVICES
SHANTHA
BIOTECHNICS
WNS
BIOLOGICAL E.
LTD
GSK KINAPSE NOVARTIS
SIRO
CLINPHARM
WOCKHARDT
BLUEFISH HCL LAMBDA NOVO NORDISK
SRI KRISHNA
PHARMA
4C Pharma
Solutions

46. Important
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