Duties of regulatory affairs professionals MCQs With Answer

Regulatory affairs professionals ensure medicines reach patients safely and legally by managing regulatory strategy, submissions, and compliance. This introduction covers core duties of regulatory affairs professionals MCQs With Answer tailored for B. Pharm students, including drug registration, dossier preparation, labeling, GMP, clinical trial applications (IND/CTA), marketing authorization (NDA/MAA), pharmacovigilance, post-marketing obligations, and liaison with agencies like FDA and EMA. Understanding regulatory pathways, quality assurance, regulatory intelligence, and documentation control prepares B. Pharm graduates for roles in industry and helps integrate science with regulatory policy. These MCQs reinforce practical knowledge, critical thinking, and exam skills relevant to coursework and entry-level regulatory roles. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which document format is standard for submitting a marketing authorization dossier in most ICH regions?

• Paper dossier with annexes
• eCTD (electronic Common Technical Document)
• Simple PDF zipped archive
• CSV structured submission

Correct Answer: eCTD (electronic Common Technical Document)

Q2. What is the primary responsibility of a regulatory affairs professional during clinical development?

• Designing clinical trial protocols
• Preparing and submitting IND/CTA to regulatory authorities
• Conducting laboratory assays
• Recruiting study participants

Correct Answer: Preparing and submitting IND/CTA to regulatory authorities

Q3. Which regulatory activity focuses on monitoring adverse drug reactions after product launch?

• Stability testing
• Pharmacovigilance
• Formulation development
• Analytical method validation

Correct Answer: Pharmacovigilance

Q4. What is a Common Technical Document (CTD) modules structure intended to organize?

• Clinical trial site lists
• Regulatory correspondence only
• Drug development information into harmonized modules
• Marketing materials and advertising claims

Correct Answer: Drug development information into harmonized modules

Q5. For a generic drug approval in many regions, which study is typically required to demonstrate equivalence?

• Pediatric clinical trial
• Bioequivalence study
• Long-term carcinogenicity study
• Whole genome sequencing

Correct Answer: Bioequivalence study

Q6. Which regulatory filing is most relevant when seeking marketing approval for a novel new chemical entity in the US?

• ANDA
• IND
• NDA
• DMF

Correct Answer: NDA

Q7. What is the purpose of a Drug Master File (DMF)?

• Registering a finished product’s label
• Providing confidential detailed information about an active ingredient or component to regulators
• Listing clinical investigator details
• Summarizing marketing plans

Correct Answer: Providing confidential detailed information about an active ingredient or component to regulators

Q8. Which regulatory concept involves planned submissions after initial approval to manage post-approval changes?

• Variations and post-approval change management
• Clinical hold
• Pre-submission meeting
• Good Laboratory Practice

Correct Answer: Variations and post-approval change management

Q9. What is the regulatory significance of GMP inspections for a manufacturing site?

• They certify marketing exclusivity
• They assess compliance with Good Manufacturing Practices to ensure product quality
• They replace the need for stability data
• They determine pricing controls

Correct Answer: They assess compliance with Good Manufacturing Practices to ensure product quality

Q10. Which timeline is critical for expedited reporting of serious unexpected adverse reactions in many regions?

• Annual
• 7–15 days (accelerated reporting window)
• 60 days
• Biannually

Correct Answer: 7–15 days (accelerated reporting window)

Q11. What role does regulatory intelligence play in regulatory affairs?

• It defines laboratory SOPs
• It monitors evolving regulations and agency guidance to inform strategy
• It manages clinical trial recruitment
• It performs routine QC testing

Correct Answer: It monitors evolving regulations and agency guidance to inform strategy

Q12. Which of the following is a key element of a marketing authorization application (MAA) dossier?

• List of competitors’ sales figures
• Comprehensive quality, safety, and efficacy data
• Employee payroll records
• Retail distribution agreements

Correct Answer: Comprehensive quality, safety, and efficacy data

Q13. In regulatory submissions, what does comparability assessment address?

• Comparing marketed prices across countries
• Showing that changes in manufacturing do not adversely affect product quality or performance
• Comparing different clinical sites
• Comparing packaging artwork designs

Correct Answer: Showing that changes in manufacturing do not adversely affect product quality or performance

Q14. Which regulatory pathway is designed to speed approval for drugs that treat serious conditions with unmet medical need?

• Standard review only
• Expedited pathways like Fast Track, Breakthrough Therapy, or Priority Review
• Routine notification
• Over-the-counter switch

Correct Answer: Expedited pathways like Fast Track, Breakthrough Therapy, or Priority Review

Q15. What is the primary focus of labeling review by regulatory affairs?

• Graphic design aesthetics
• Ensuring safety, efficacy information, and regulatory compliance in product labeling
• Setting retail price
• Choosing carton materials

Correct Answer: Ensuring safety, efficacy information, and regulatory compliance in product labeling

Q16. Which document summarizes chemistry, manufacturing, and controls (CMC) information?

• Investigator’s brochure
• Module 3 of the CTD
• Protocol consent form
• Marketing plan

Correct Answer: Module 3 of the CTD

Q17. For biosimilars, which regulatory challenge is typically more complex than for small-molecule generics?

• Demonstrating identical chemical structure by simple assays
• Demonstrating similarity through comparative analytical and clinical data
• Submitting only a certificate of analysis
• Skipping pharmacovigilance requirements

Correct Answer: Demonstrating similarity through comparative analytical and clinical data

Q18. What is an Investigator’s Brochure (IB) mainly used for?

• Providing detailed product marketing materials to pharmacies
• Providing clinical investigators with clinical and nonclinical data relevant to a trial
• Detailing manufacturing batch records
• Listing distribution channels

Correct Answer: Providing clinical investigators with clinical and nonclinical data relevant to a trial

Q19. Which regulatory document defines how to assess product stability over time?

• Statistical analysis plan
• Stability protocol and stability study report
• Pharmacoeconomic dossier
• Clinical study synopsis

Correct Answer: Stability protocol and stability study report

Q20. What is the role of a pre-submission meeting with a regulatory agency?

• To obtain a marketing exclusivity certificate
• To seek agency feedback on development plans and submission strategy
• To register manufacturing equipment
• To recruit clinical trial subjects

Correct Answer: To seek agency feedback on development plans and submission strategy

Q21. Which international initiative harmonizes technical requirements for pharmaceuticals among major regions?

• GMP Alliance
• ICH (International Council for Harmonisation)
• WHO Export Program
• ISO Clinical Standards

Correct Answer: ICH (International Council for Harmonisation)

Q22. When preparing an eCTD submission, which activity is essential before final submission?

• Designing the product label artwork
• Validation of the eCTD structure and XML backbone
• Conducting final clinical visits
• Obtaining market share forecasts

Correct Answer: Validation of the eCTD structure and XML backbone

Q23. Which regulatory filing is used to seek approval for changes in an already authorized medicinal product?

• Initial MAA only
• Variation or supplement application
• Clinical trial termination notice
• Preclinical data package

Correct Answer: Variation or supplement application

Q24. What is the primary regulatory concern when selecting excipients for a formulation?

• Cost only
• Safety, compatibility, and regulatory approval status of excipients
• Color matching with competitor products
• Patent filing strategy

Correct Answer: Safety, compatibility, and regulatory approval status of excipients

Q25. How do regulatory affairs professionals contribute to risk management for a product?

• By designing manufacturing equipment
• By developing risk management plans and pharmacovigilance strategies
• By conducting marketing campaigns
• By running quality control labs

Correct Answer: By developing risk management plans and pharmacovigilance strategies

Q26. Which concept involves linking patent status and regulatory approval for generics in some jurisdictions?

• Good Clinical Practice
• Patent linkage
• ICH harmonization
• Bioavailability waiver

Correct Answer: Patent linkage

Q27. What is a key responsibility when managing labeling changes across multiple markets?

• Submitting one global label for all markets regardless of local laws
• Ensuring local regulatory requirements and translations are met
• Ignoring pharmacovigilance inputs
• Changing formulation without notification

Correct Answer: Ensuring local regulatory requirements and translations are met

Q28. In the context of regulatory submissions, what is ‘regulatory gap analysis’ used for?

• Predicting market sales
• Identifying missing data or documentation needed for submission
• Ranking suppliers by cost
• Scheduling manufacturing runs

Correct Answer: Identifying missing data or documentation needed for submission

Q29. Which document provides nonclinical safety data relevant to early human trials?

• Clinical study report
• Nonclinical study reports included in the IB and CTD Module 4
• Marketing authorization certificate
• Packaging specification

Correct Answer: Nonclinical study reports included in the IB and CTD Module 4

Q30. What is an essential skill for regulatory affairs professionals working across global submissions?

• Fluency in one local dialect only
• Understanding international regulations, strong documentation skills, and cross-cultural coordination
• Only laboratory bench skills
• Exclusive focus on sales strategies

Correct Answer: Understanding international regulations, strong documentation skills, and cross-cultural coordination

G S Sachin

I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.

Mail- Sachin@pharmacyfreak.com