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Pharmaids Pharmaceuticals Regulatory Affairs Manager Interview Questions, Process, and Tips
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Regulatory Affairs Manager Interview Questions & Answers
sunilkumar anumalasetty
posted on 23 Dec 2019
I applied via Referral and was interviewed in Nov 2019. There were 4 interview rounds.
Interview Questionnaire
12 Questions
- Q1. DMF submission purpose what is the additional requirements
- Q2. DMF specification for China which batches and specification will use
- Q3. There is an submission in other regions for a drug substance, china will accept or not
- Q4. What is an purging stidy
- Ans.
A purging study is a research study conducted to evaluate the effectiveness of a purging process in removing impurities or contaminants.
A purging study is typically conducted in industries such as pharmaceuticals, food processing, and manufacturing.
The study involves testing the efficiency of a purging process in eliminating unwanted substances.
It may include analyzing samples before and after the purging process to me...
- Q5. Explain about a change in china
- Q6. Specifically the chemical isomeric positions or how many isomers in that product
- Q7. What is nitrosamine impurities
- Q8. What limits consider for nitrosamine impurities
- Ans.
Limits for nitrosamine impurities in regulatory affairs
Consider the acceptable daily intake (ADI) for nitrosamines
Refer to regulatory guidelines and requirements for specific limits
Evaluate the potential risk and toxicity of nitrosamines
Take into account the route of administration and dosage form
Consider the level of nitrosamine impurities in raw materials and finished products
Monitor and analyze data from stability s...
- Q9. How to calculate ttc for a drug substance and the formula
- Q10. The calculation used per as per ICHM7, with the formula 1.5/maximum daily dose in mg for option 1
- Q11. Explain about in handling of changes submission in US and EU
- Q12. Based on the guidance the US the changes and EUhas explained along with example, in US, CBE-0, CBE-30, PAS, in Europe Type-1, (Type-1A, Type-1B) and Type-II
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