Regulatory Affairs is a profession in the pharmaceutical industry that acts as the interface between the drug safety authorities and the pharmaceutical industry in India and across the world. It is mainly responsible for registering the drug or new pharmaceutical products in different respective countries before marketing.
There are several interview questions you could be asked during the application for a regulatory affairs role, and the questions involved vary based on the specific role you are applying for. Here are a few of our top interview questions for Regulatory affairs interviews to help you succeed:
1. What is Regulatory Affairs?
Ans- Regulatory Affairs is a field that ensures the safety, efficacy, and quality of products, primarily in the pharmaceutical, and medical device industries. Regulatory professionals are responsible for negotiating complex regulations, submitting applications, and interacting with regulatory agencies to ensure product compliance.
2. What are the Roles and responsibilities of the Regulatory Affairs Officer?
Ans- The main responsibilities of a Regulatory Affairs Officer include:
- Analysing and ensuring the safety and efficacy of the new pharmaceutical product.
- Monitoring and staying updated about Regulatory changes.
- Preparing and submitting regulatory documents such as IND, NDA etc.
- Responding to all regulatory inquiries from agencies.
- Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, and GLP guidelines, regulations and laws.
3. What Regulatory agencies are involved in the Pharma industry?
Ans- The Regulatory agencies involved in the pharmaceutical industry are:
- Food and Drug Administration (FDA) in the United States.
- Pharmaceutical and Medical Devices Agency in Japan (PDMA)
- Health Canada in Canada.
- European Medicines Agency (EMA) in Europe.
- National Medical Products Administration (NMPA) in China.
- Central Drugs Standard Control Organization (CDSCO) in India
4. What are the different phases of the Clinical Trials?
Ans- Clinical trials are divided into four parts, they are
Phase 1 – In this part, the safety and dosage of the drug are evaluated in a small group of healthy volunteers.
Phase 2 – the efficacy and safety of the product as assessed in the larger group of patients with the target disease
Phase 3 – Large-scale trials are conducted to confirm efficacy, safety, and optimal dosage for the target population.
Phase 4 – Post-marketing surveillance is done to monitor the long-term safety and efficacy in the broader population.
5. What is a New Drug Application (NDA)?
Ans- A New Drug Application (NDA) is a type of application in which a pharmaceutical manufacturer or its agent requests permission from the U.S. Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications.
6. What is an Investigational New Drug Application (IND)?
Ans- An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. It contains details about the drug, manufacturing processes, and proposed clinical trial plans.
7.What is an Abbreviated New Drug Application (ANDA??
Ans- Abbreviated New Drug Application is a request to the FDA to approve a generic drug that is similar to an approved drug. The ANDA ensures the safety and efficacy of the generic drug.
8. What are Generic Drugs?
Ans- A generic drug is a product that is comparable to the original innovator drug in terms of dosage, strength, administration route and treatment intended use.
9. What is ICH?
Ans- ICH stands for International Council for Harmonization. It is a body which makes recommendations on information that should be included in the core clinical study report of an individual study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects.
10. What are ICH guidelines?
Ans- ICH guidelines were created by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. They are divided into four parts. They are developed by regulatory and pharma industry authorities.
- Quality guidelines
- Safety guidelines
- Efficacy guidelines
- Multidisciplinary guidelines.
11. What is a Good Manufacturing Practice (GMP)?
Ans- Good Manufacturing Practice is a set of rules and regulations that define the minimum standards for the manufacturing and quality control of pharmaceuticals and medical devices. It ensures that products are consistently produced and meet predetermined quality standards. GMP is essential for ensuring product safety, efficacy, and quality control, protecting public health.
12. What is GCP?
Ans- GCP stands for good clinical Practices, It is an international ethical and scientific standard for conducting biomedical and behavioural research. It specifies good clinical practice guidelines for all aspects of a study, from trial documentation and protocol amendments to reporting lines for adverse events and medical care available for participants in trials testing pharmaceuticals for human use.
13. What are the 4 stages of drug development?
Ans- The four stages of Drug Development Phases are:
- Phase 1: Discovery and Development.
- Phase 2: Preclinical Research.
- Phase 3: Clinical Research.
- Phase 4: FDA Review.
- Phase 5: FDA Post-Market Safety Monitoring.
14. What is DMF?
Ans- DMF stands for Drug Master Files. It is a confidential document containing detailed information about the manufacturing, processing, packaging and storage of human drugs. It is submitted to the FDA.
15. What are the different types of DMF?
Ans- There are five types of Drug Master Files:
- Manufacturing Site, Facilities, Operating Procedures, and Personnel
- Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Packaging Material
- Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- FDA Accepted Reference Information
16. How do you stay updated with regulatory changes?
Ans- To stay updated with regulatory changes, I regularly review updates from regulatory agencies like the FDA, EMA, and ICH. Subscribing to newsletters, participating in webinars, attending conferences, and being a member of professional organizations in the field also help in staying informed about the latest developments.
17. What is CMC in Regulatory Affairs?
Ans- CMC stands for Chemistry, Manufacturing, and Controls. It refers to the technical and regulatory aspects of drug development and production, which includes the chemical composition of the drug substance, its manufacturing process, and the controls in place to ensure its quality and consistency.
18. What steps would you take if you encounter a regulatory non-compliance issue?
Ans- Upon encountering a regulatory non-compliance issue, the steps include:
- I would conduct a thorough investigation to understand the root cause of the non-compliance
- Documenting the issues and the investigation findings
- I would implement corrective and preventive actions to address the issue
- Informing and communicating with the relevant regulatory authorities if required
- Ensuring all necessary reporting is completed.
19. What is a Risk Management Plan (RMP) in Regulatory Affairs?
Ans- A Risk Management Plan (RMP) is a detailed document submitted to regulatory authorities that outlines the strategies and actions that will be taken to identify, assess, and mitigate the risks associated with a pharmaceutical product. It includes information on the drug’s safety profile, how risks will be monitored, and what measures will be put in place to minimize those risks.
20. What is a Dossier in Regulatory Affairs?
Ans- In regulatory affairs, a dossier is a term used to describe a compilation and array of documents regarding the safety, efficacy, and quality information of a medical product. The dossier is to be submitted to a regulatory authority for review, and approval of the submission would grant the product marketing authorization.
21. How do you create a Dossier?
Ans- To create a dossier on the home page or any folder page you should click Create and then select New Dossier. Your dossier is created and displayed, containing a single blank visualization.
22. What are the three parts of a dossier?
Ans- The dossier consists of two basic components: a teaching narrative statement or philosophy, which is a short reflective narrative (two to three pages), and an appendix, which consists of supporting documentation.
23. What are some challenges faced by the pharma companies?
Ans- Some Regulatory challenges include:
- Meeting strict quality standards and documentation requirements
- Ensuring compliance with international regulations for global markets
- Navigating complex regulations
- Managing timelines for regulatory submissions
24. How would you handle a situation where a product does not meet regulatory requirements?
Ans- I would follow certain steps to handle this situation:
- I would investigate thoroughly and try to find out the reason for the con compliance
- Discuss the issue with the relevant stakeholders, and management and inform the regulatory agency.
- Work and collaborate with the cross-functional teams to develop and implement corrective actions
- I would make sure that the documentation is maintained throughout the process and investigation.
25. What is 505(b)(2) Application?
Ans- The 505(b)(2) application is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a section of the Federal Food, Drug, and Cosmetic Act. The provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved drug. The section gives the FDA express permission to rely on data not developed by the NDA applicant.
26. What Kind Of Application Can Be Submitted As a 505(b)(2) Application?
Ans – Applications such as New chemical entity (NCE) and Changes to previously approved drugs can be submitted as a 505(b)(2) application.
27. What is MAA in Regulatory Affairs?
Ans- MAA stands for Marketing Authorization Application. It is an application submitted to the European Medicines Agency (EMA) to market a medicinal product in the EU member states.
28. What is the role of a Quality Management System in Regulatory Affairs?
Ans A Quality Management System provides a framework for ensuring the quality of products, processes, and systems throughout the product life cycle. It helps Regulatory Affairs professionals demonstrate compliance with regulations, track product performance, and manage risks. Key components of a QMS include document control, change management, risk management and auditing.
29. What is ASMF?
Ans- ASMF stands for Active Substance Master File (ASMF). It is a crucial document in the pharmaceutical industry, providing a comprehensive account of the active substance used in the manufacturing of a drug. This document is instrumental for regulatory authorities in assessing the quality and safety of the active substances incorporated in pharmaceutical products. The ASMF contains detailed information about the manufacturing, control, storage, and stability of an active pharmaceutical ingredient (API), ensuring that the end pharmaceutical product is of high quality, safe, and effective for patient use.
30. What is CTD in Regulatory Affairs?
Ans-CTD stands for Common Technical Document. It is a set of specifications for a dossier for the registration of medicines. The CTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and adopted by the Therapeutic Goods Administration (TGA) in 2004.
31. What are the modules of Common Technical Affairs?
Ans- The modules of Common Technical Affairs Include:
- Module 1: Administrative information and prescribing information for Australia
- Module 2: Common technical document summaries
- Module 3: Quality
- Module 4:Safety (Non-clinical study reports)
- Efficacy (clinical study reports)
32. What is the role of a regulatory affairs professional in a pharmaceutical company’s drug development process?
Ans The following are the roles of a Regulatory affairs professional from preclinical to post marketing phase:
- Preclinical development: Providing guidance on regulatory requirements for preclinical studies and ensuring adherence to Good Laboratory Practices (GLP).
- Clinical trial design: Collaborating with clinical teams to ensure trial protocols meet regulatory requirements and align with the drug’s development plan.
- Regulatory submissions: Preparing and submitting applications (e.g., IND, NDA) to regulatory agencies, ensuring accuracy and completeness of data.
- Post-marketing surveillance: Monitoring the safety and efficacy of approved drugs, responding to adverse event reports, and participating in pharmacovigilance activities.
33. What is IEC?
Ans- IEC stands for Indian Ethics Committee.
34. What is CEP in Regulatory Affairs?
Ans- CEP stands for The Certification of Suitability. It is a certificate that certifies compliance of the active pharmaceutical ingredients (API) or pharmaceutical ingredients with the rules laid down in the monograph of the European Pharmacopoeia (EP).
35. What are some skills that you believe are important for a Regulatory Affairs professional?
Ans- Some skills that are important for regulatory Affairs professionals are:
- Strong organizational and time management skills.
- Proficiency in relevant software and databases.
- Effective communication and interpersonal skills.
- Strong understanding of regulatory requirements.
- Excellent analytical and problem-solving skills.
- Ability to work independently and as part of a team.
- Meticulous attention to detail and accuracy.
