Regulatory Affairs in Pharmaceutical industry I RA department l Interview questions and answers
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Questions covered:
Q. What is the responsibility of Regulatory Affairs (RA) department of a pharmaceutical company?
Q. What is the role of regulatory affairs in pharmaceutical R&D ?
Q. Which are the top 10 regulatory agencies in pharmaceutical industry ?
Q. Which activities RA regulates ?
Q. What is orange book ?
Q.: What is 180 day exclusivity ?
Q. What are DMF and their types ?
Q. What is NDA and ANDA filing ?
Q. What is difference between law and regulation in pharmaceutical industry?
Q. What is difference between regulated market and non-regulated market ?
Q. What is technical pack ?
Q. What is CTD and eCTD?
Q. Describe the Drug Master File (DMF) and its purpose ?
Q. What is a Certificate of Pharmaceutical Product (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 the submission of a Variation to an existing marketing authorization?
Q. Explain the Orphan Drug Designation and its significance ?
Q. How does a change in manufacturing processes affect regulatory submissions ?
Q. Describe the role of regulatory affairs in ensuring the compliance of labeling and packaging ?
Q. How does the ICH (International Conference on Harmonisation) impact global regulatory affairs?
Q. How does the Hatch-Waxman Act impact regulatory affairs?
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 regulatory affairs in the approval of clinical trial protocols ?
Q. How do you address post-approval changes for a marketed drug?
Q. What are the key considerations for regulatory affairs professionals when managing a pharmaceutical product's lifecycle?
Q. Which are the top 10 Global regulatory guidelines in the pharmaceutical industry ?
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