Ipca Laboratories Manager Medical Affairs Interview Questions and Answers

Q1. Personal details
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Q2. Work experience
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Q1. Why change company What is your understanding about variations
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Q1. Types of variation
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Q2. Procedures for variation
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Q3. Examples of variation and was asked under which category it will fall
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Q1. How do you file an ANDA with excipients not matching the RLD? What is design space?
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Q1. Work related as per submitted resume
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Q2. Based on work explosure of prevoius company
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Q1. Submitted resume
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Q1. What is tablet? Process of tablet production?
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Q2. What is physical stability
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Q3. What is granulation?
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Q1. Family background, questions about yourself
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Q1. ICH Stability Guideline
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Q2. Photostability conditions
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Q3. US FDA RTR Criteria- Major n Minor
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Q4. Packaging Case Study
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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
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Q1. ANDA requirements for Liquid Products
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Q2. Specification requirements for OSD N Loquid products
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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
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Q1. Expected salary n justification
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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
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Q2. Notice period - is it negotiable
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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.
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Q2. Some basics B Pharm level questions.
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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
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Q2. Explain ich guidelines
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Q3. Types of ich guidelines
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