Finding another job can be so cumbersome that it can turn into a job itself. Prepare well for the job interviews to get your dream job. Here's our recommendation on the important things to You need to prepare for the job interview to achieve your career goals in an easy way. Regulatory Affairs is a government job handling the central affairs in fields such as industries, pharma, banking, energy, telecom etc. Their responsibilities are - working with federal, state, and local regulatory agencies, ensuring that their companies comply with all of the regulations and many more. Strong determination is required to crack the job. Follow our Wisdomjobs page for Regulatory Affairs job interview questions and answers page to get through your job interview successfully in first attempt.
Question 1. What Is Regulatory Affairs?
Answer :
Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing.
Question 2. What Are The Goals Of Regulatory Affairs Professionals?
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Question 3. What Are The Roles Of Regulatory Affairs Professionals?
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Question 4. What Is An Investigational New Drug (ind) Application?
Answer :
It is an application which is filed with FDA to get approval for legally testing an experimental drug on human subjects in the USA.
Question 5. What Is A New Drug Application?
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The NDA is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDA
In simple words, “It is an application which is filed with FDA to market a new Pharmaceutical for sale in USA”
Question 6. What Is An Abbreviated New Drug Application (anda)?
Answer :
It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or approved drug.
In simple words, “It is an application for the approval of Generic Drugs “
Question 7. What Is A Generic Drug Product?
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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.
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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.
Important facts regarding DMFs :
Question 9. What Are The Types Of Dmf’s?
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Question 10. What Is A 505 (b)(2) Application ?
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505 (b)(2) application is a type of NDA for which one or more investigations relied on by applicant for approval were not conducted by/for applicant and for which applicant has not obtained a right of reference.
Question 11. What Kind Of Application Can Be Submitted As A 505(b)(2) Application?
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Question 13. What Are The Chemical Classification Codes For Nda?
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Question 14. What Are The Differences Between Nda And 505 (b)(2) Application?
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New Drug Application (NDA) :
505 (b)(2) Application :
Question 15. What Is A Marketing Authorization Application?
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It is an application filed with the relevant authority in the Europe (typically, the UK's MHRA or the EMA’s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine.
As per UK’s MHRA-
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Active substance master file is a submission which is made to EMA, MHRA or any other Drug Regulatory Authority in Europe to provide confidential intellectual property or 'know-how' of the manufacturer of the active substance.
In simple words, “It is a submission made to European Drug regulatory agencies on the confidential information of Active Substance or Active pharmaceutical Ingredient (API)”.
Question 17. What Are The Types Of Active Substances For Which Asmfs Are Submitted?
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Question 18. What Is The Difference Between Dmf And Asmf (with Respect To Submission)?
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International Conference on Harmonisation 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.
Answer :
The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.
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Question 22. What Are The Modules In Ctd?
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The Common Technical Document is divided into five modules:
Question 23. What Is Orange Book?
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It is the commonly used name for the book “Approved Drug Products with Therapeutic Equivalence Evaluations”, which is published by USFDA.
It contains the list of drug products, approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.
Question 24. What Is Hatch-waxman Act?
Answer :
It is the popular name for Drug Price Competition and Patent Term Restoration Act, 1984. It is considered as the landmark legislation which established the modern system of generic drugs in USA. Hatch-Waxman amendment of the federal food, drug and cosmetics act established the process by which, would be marketers of generic drugs can file 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.
In simple words “Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics ”
Question 25. What Are The Patent Certifications Under Hatch-waxman Act?
Answer :
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:
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.
Question 26. What Is Meant By 180 Day Exclusivity?
Answer :
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 having to defend a patent infringement suit.
180 Day Exclusivity could be granted to more than one applicant. The recent example is- 180 day exclusivity was granted to Ranbaxy and Watson Laboratories for marketing generic version of Lipitor ( Atorvastatin calcium).
Question 27. What Are The Procedures For Approval Of Drug In Eu?
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Question 28. What Is The Full Form Of Abbreviation, Cep?
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Certificate of Suitability to the monographs of the European Pharmacopoeia (or) Certificate of suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European Pharmacopoeia monographs
It is also informally referred to as Certificate of Suitability (COS)
Answer :
It is the certificate which is issued by Certification of Substances Division of European Directorate for the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.
Question 30. What Are The Well Known Drug Regulatory Agencies Across The World?
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