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Pharmaids Pharmaceuticals Regulatory Affairs Manager Interview Questions, Process, and Tips

Updated 24 Dec 2019

Pharmaids Pharmaceuticals Regulatory Affairs Manager Interview Experiences

1 interview found

Regulatory Affairs Manager Interview Questions & Answers

user image 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...

  • Answered by AI
  • 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...

  • Answered by AI
  • 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

Interview Preparation Tips

Interview preparation tips for other job seekers - Very good interview and make a knowledge along with practice and guidance.

Skills evaluated in this interview

Interview questions from similar companies

Interview experience
4
Good
Difficulty level
Moderate
Process Duration
Less than 2 weeks
Result
Selected Selected

I applied via Company Website and was interviewed before Dec 2022. There were 4 interview rounds.

Round 1 - Resume Shortlist 
Pro Tip by AmbitionBox:
Double-check your resume for any spelling mistakes. The recruiter may consider spelling mistakes as careless behavior or poor communication skills.
View all tips
Round 2 - Technical 

(3 Questions)

  • Q1. Technical followed by HR
  • Q2. Related to quality assurance questions
  • Q3. OOS, OOT, investigation, deviation
Round 3 - One-on-one 

(1 Question)

  • Q1. Technical head will ask questions
Round 4 - HR 

(1 Question)

  • Q1. Salary discussion and negotiations

Interview Preparation Tips

Topics to prepare for Oman Pharmaceutical Products Associate Manager interview:
  • Compliance
  • Manufacturing
Interview preparation tips for other job seekers - Only experience people will be Obsorbed
Interview experience
5
Excellent
Difficulty level
Moderate
Process Duration
Less than 2 weeks
Result
Selected Selected

I applied via LinkedIn and was interviewed before Apr 2023. There were 2 interview rounds.

Round 1 - Technical 

(1 Question)

  • Q1. Basic syntax related questions and checking your logical thinking when it comes to coding
Round 2 - One-on-one 

(1 Question)

  • Q1. Complex SQL and python questions related to data analysis and management
Interview experience
4
Good
Difficulty level
Easy
Process Duration
Less than 2 weeks
Result
No response

I applied via LinkedIn and was interviewed in Nov 2023. There were 3 interview rounds.

Round 1 - Resume Shortlist 
Pro Tip by AmbitionBox:
Properly align and format text in your resume. A recruiter will have to spend more time reading poorly aligned text, leading to high chances of rejection.
View all tips
Round 2 - HR 

(2 Questions)

  • Q1. Basic introduction
  • Q2. Previous experience
Round 3 - Technical 

(3 Questions)

  • Q1. SQL related questions
  • Q2. Quarry optimisation
  • Q3. Windows function
Interview experience
1
Bad
Difficulty level
Moderate
Process Duration
Less than 2 weeks
Result
Selected Selected

I applied via Indeed and was interviewed before Sep 2022. There were 2 interview rounds.

Round 1 - Resume Shortlist 
Pro Tip by AmbitionBox:
Properly align and format text in your resume. A recruiter will have to spend more time reading poorly aligned text, leading to high chances of rejection.
View all tips
Round 2 - HR 

(5 Questions)

  • Q1. Why you want to join auxein?
  • Q2. Personal Details
  • Q3. Last company working detail
  • Q4. Why you left last company
  • Q5. Are you comfortablehere

Interview Preparation Tips

Interview preparation tips for other job seekers - HR round do easily

I applied via Company Website and was interviewed in Feb 2021. There was 1 interview round.

Interview Questionnaire 

1 Question

  • Q1. Tell me about ur self
  • Ans. I'm tenzing thapa from imphal after completed mi high secondary examination on 2016 after trying for army recruitment but unfortunately not selected. So again I continue mi for paper for BA ist year ...and between I worked on medical store ..leats for 2 years and i had completed my BA final paper. So currently working at Azkka pharmaceutical
  • Answered Anonymously

Interview Preparation Tips

Interview preparation tips for other job seekers - I had an interview after 3 days HR fixed interview with sale director he told me all the best

I applied via Referral and was interviewed in Jul 2021. There was 1 interview round.

Interview Questionnaire 

1 Question

  • Q1. Role of medical representative

Interview Preparation Tips

Interview preparation tips for other job seekers - I expected the interview rounds to be good

I applied via Recruitment Consultant and was interviewed before Aug 2020. There were 3 interview rounds.

Interview Questionnaire 

4 Questions

  • Q1. Production documents technical questions
  • Q2. Flow of documents
  • Ans. 

    The flow of documents is crucial for efficient operations and decision-making.

    • Establish clear protocols for document creation, review, and approval.

    • Use technology to streamline document management and ensure accessibility.

    • Train employees on proper document handling and storage.

    • Regularly review and update document policies to reflect changes in regulations or business practices.

  • Answered by AI
  • Q3. How to revise document
  • Ans. 

    To revise a document, review it for errors, clarity, and consistency.

    • Read through the document multiple times

    • Check for spelling and grammar errors

    • Ensure the document is clear and concise

    • Verify that the document is consistent in formatting and style

    • Ask a colleague to review the document for a fresh perspective

  • Answered by AI
  • Q4. Audit compliance

Interview Preparation Tips

Interview preparation tips for other job seekers - Always face interview with preparation regarding job offer and self confidence.

I applied via Walk-in and was interviewed in Apr 2021. There was 1 interview round.

Interview Questionnaire 

2 Questions

  • Q1. Related to respected area experience
  • Q2. Like normal values of electrolytes, solution used for carbolization, if ot means common instrument name

Interview Preparation Tips

Interview preparation tips for other job seekers - Answer everything with confident

I applied via Naukri.com and was interviewed before Oct 2020. There was 1 interview round.

Interview Questionnaire 

3 Questions

  • Q1. Tell me something about yourself?
  • Ans. 

    I am a creative and detail-oriented marketing professional with experience in social media management and event planning.

    • I have a Bachelor's degree in Marketing and Communications

    • I have worked as a Marketing Assistant for a tech startup

    • I am proficient in Adobe Creative Suite and Hootsuite

    • I have planned and executed successful product launch events

    • I am passionate about staying up-to-date with the latest marketing trends

  • Answered by AI
  • Q2. Why do you want to join as a Marketing Coordinator?
  • Ans. 

    I am passionate about marketing and want to utilize my skills to contribute to the success of the company as a Marketing Coordinator.

    • I have a degree in marketing and have gained experience through internships and previous jobs.

    • I am excited about the opportunity to work with a team and collaborate on marketing strategies.

    • I am eager to learn and grow in my career as a marketing professional.

    • I am impressed with the compan...

  • Answered by AI
  • Q3. How you are fit for the role of Marketing Coordinator? How will it benefit the company?
  • Ans. 

    As a Marketing Coordinator, I have the skills and experience to create effective marketing strategies and campaigns that will benefit the company.

    • I have a degree in marketing and several years of experience in the field.

    • I am skilled in market research, social media marketing, and content creation.

    • I have a proven track record of increasing brand awareness and driving sales.

    • I am a team player and can work collaboratively...

  • Answered by AI

Interview Preparation Tips

Interview preparation tips for other job seekers - Be confident. Don't mug up things. Point out your strengths and how you can put them into your work. Be patient throughout the process of the interview.

Pharmaids Pharmaceuticals Interview FAQs

What are the top questions asked in Pharmaids Pharmaceuticals Regulatory Affairs Manager interview?

Some of the top questions asked at the Pharmaids Pharmaceuticals Regulatory Affairs Manager interview -

  1. DMF submission purpose what is the additional requireme...read more
  2. What limits consider for nitrosamine impurit...read more
  3. How to calculate ttc for a drug substance and the form...read more

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