Aculife Healthcare Regulatory Affairs Officer Interview Questions and Answers

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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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Q1. Self introduction basics and your JD
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Q1. Validation strategy for ANDA submissions.
Ans. 
The validation strategy for ANDA submissions involves ensuring the accuracy and reliability of data and documentation.
• Develop a comprehensive validation plan that outlines the objectives, scope, and approach for the ANDA submission.

• Perform validation activities such as analytical method validation, process validation, and cleaning validation.

• Ensure compliance with regulatory guidelines and requirements, such as FDA's G...read more
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Q1. Tell me about yourself
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Q2. Basic communication skills
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Q1. Tell me briefly about yourself
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Q2. What did you do in your project
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Q3. What do know about ra
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Q1. Human Resources ROund
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Q2. Technical round
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Q1. Explain ich guidelines
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Q1. Analytical method Validation
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Q1. 1.Basic details of yourself 2. Subject knowledge about previous education
Ans. Brief introduction of yourself in a good fluency and knowledge about previous education
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Q2. Basic idea about department
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