Intas Pharmaceuticals Regulatory Affairs Associate Interview Questions and Answers

Q1. Personal details
Add your answer
Q2. Work experience
Add your answer

Q1. How do you file an ANDA with excipients not matching the RLD? What is design space?
Add your answer

Q1. Work related as per submitted resume
Add your answer
Q2. Based on work explosure of prevoius company
Add your answer

Q1. Submitted resume
Add your answer

Q1. What is DMF, modules in DMF, What is validation & different parameters of validation as per ICH Q2(R1)
Add your answer

Q1. Basic questions regarding your previous job
Add your answer

Q1. What is tablet? Process of tablet production?
Add your answer
Q2. What is physical stability
Add your answer
Q3. What is granulation?
Add your answer

Q1. Family background, questions about yourself
Add your answer

Q1. ICH Stability Guideline
Add your answer
Q2. Photostability conditions
Add your answer
Q3. US FDA RTR Criteria- Major n Minor
Add your answer
Q4. Packaging Case Study
Add your answer
Q5. Requirements for Flavours
Ans. 
Requirements for flavours in regulatory affairs include safety assessments, compliance with regulations, and accurate labeling.
• Flavours must be safe for consumption and not pose any health risks.

• Regulatory agencies may have specific guidelines for the use of flavours in certain products.

• Accurate labeling of flavours is essential for consumer transparency and safety.

• Examples of regulations include FDA regulations in the
Answered by AI
Add your answer

Q1. ANDA requirements for Liquid Products
Add your answer
Q2. Specification requirements for OSD N Loquid products
Ans. 
Specification requirements for OSD N Liquid products include physical and chemical properties, stability, purity, and packaging details.
• Physical and chemical properties such as appearance, color, odor, pH, viscosity, and density

• Stability testing to ensure product remains effective throughout its shelf life

• Purity testing to confirm absence of impurities or contaminants

• Packaging details including container material, clos
Answered by AI
Add your answer

Q1. Expected salary n justification
Ans. 
My expected salary is based on my experience, education, industry standards, and the value I can bring to the company.
• My expected salary is in line with industry standards for Regulatory Affairs Specialists.

• I have X years of experience in regulatory affairs, which justifies my salary expectations.

• I hold a relevant degree in regulatory affairs or a related field, which adds value to my candidacy.

• I have a track record of...read more
Answered by AI
Add your answer
Q2. Notice period - is it negotiable
Add your answer

Q1. They asked me about questions related European Regulatory submission. Question from other Regulatory domain. I felt it was easy for me as I did my M Pharmacy in Regulatory Affairs.
Add your answer
Q2. Some basics B Pharm level questions.
Add your answer

General questions are asked.....

Q1. What is regulatory affairs
Ans. 
Regulatory affairs involves ensuring compliance with regulations and guidelines in various industries.
• Regulatory affairs is a field that deals with the development, implementation, and compliance of regulations and guidelines in industries such as pharmaceuticals, medical devices, cosmetics, and food products.

• Professionals in regulatory affairs work to ensure that products and processes meet the necessary legal and qua...read more
Answered by AI
Add your answer
Q2. Explain ich guidelines
Add your answer
Q3. Types of ich guidelines
Add your answer