Regulatory Affairs in the Pharmaceutical Industry I RA Department l Interview Questions and Answers

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Go to the playlists below and search for the desired topic:

1. QMS – Quality Management System in the Pharmaceutical Industry: https://www.youtube.com/playlist?listPLWElJz3ahCNqnXftgTHiLdxM154CmoRsR
2. QA- Quality Assurance in the Pharmaceutical Industry. : https://www.youtube.com/playlist?listPLWElJz3ahCNoFfgX3bYjXwSPtO8KyK1gP
3. QC – Quality Control in the Pharmaceutical Industry: https://www.youtube.com/playlist?listPLWElJz3ahCNpvL3dRLtGjc_BRuRkx0CVT
4. OSD – Tablet production in the pharmaceutical industry: https://www.youtube.com/playlist?listPLWElJz3ahCNoSYaSlSrkdbk6j-bHTy72T
5. Injectable Processing – Injectable Processing or Sterile Dosage Formulation: https://www.youtube.com/playlist?listPLWElJz3ahCNoqGqSfdeJlBgpKfuUlQF_f

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Questions covered:
Q. What is the responsibility of the Regulatory Affairs (RA) department of a pharmaceutical company?
Q. What is the role of regulation in pharmaceutical R&D?
Q. Which are the top 10 regulatory authorities in the pharmaceutical industry?
Q. What activities does RA regulate?
Q. What is orange book?
Q.: What is 180 days of exclusivity?
Q. What are DMF and their types?
Q. What is an NDA and ANDA application?
Q. What is the difference between legislation and regulations in the pharmaceutical industry?
Q. What is the difference between a regulated market and an unregulated market?
Q. What is a technical package?
Q. What is CTD and eCTD?
Q. Describe the Drug Master File (DMF) and its purpose?
Q. What is a Pharmaceutical Product Certificate (CPP)?
Q. Explain the role of a Regulatory Affairs Specialist in the product development process?
Q. What is an Investigational New Drug (IND) application?
Q. What is a bioequivalence study and when is it required?
Q. How do you handle submitting a variation to an existing marketing authorization?
Q. Explain the orphan drug designation and its meaning?
Q. How will a change in manufacturing processes impact regulator submissions?
Q. Describe the role of regulation in ensuring compliance with labeling and packaging?
Q. How does the ICH (International Conference on Harmonization) impact global regulatory affairs?
Q. How does the Hatch-Waxman Act impact regulatory matters?
Q. What is a Common Technical Document (CTD)?
Q. What are post-marketing surveillance and pharmacovigilance?
Q. Explain the concept of Quality by Design (QbD) in pharmaceutical manufacturing?
Q. What is the role of regulation in approving clinical trial protocols?
Q. How do you handle changes after approval of a drug on the market?
Q. What are the key considerations for regulatory professionals when managing the life cycle of a pharmaceutical product?
Q. What are the top 10 global regulatory guidelines in the pharmaceutical industry?
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