10+ Executive Regulatory Affairs Interview Questions and Answers

DMF stands for Drug Master File, which contains information about the manufacturing, processing, and packaging of a drug.

• DMF is a submission made to regulatory authorities to provide confidential information about the drug's components, manufacturing process, and controls.

• Modules in DMF refer to different sections or parts of the DMF submission, each addressing specific aspects of the drug.

• Validation is the process of establishing documented evidence that a system, process, o...read more

Labeling is the process of providing information about a product on its packaging or accompanying literature.

• Labeling includes information such as ingredients, usage instructions, warnings, and storage instructions.

• Labeling is important for consumer safety and informed decision making.

• In the medical field, labeling also includes information about dosage, side effects, and contraindications.

• Examples of labeled products include food packaging, medication bottles, and cosmetic p...read more

To file an ANDA with excipients not matching the RLD, a justification must be provided. Design space refers to the range of process parameters that ensure quality.

• ANDA with different excipients requires justification for safety and efficacy.

• Provide data on excipient functionality and impact on drug product performance.

• Design space is the range of process parameters within which quality attributes are met.

• Understanding design space helps in optimizing manufacturing processes a...read more

The 6 principles of FSSAI are safety, purity, quality, legality, transparency, and accountability.

• Safety - Ensuring food is safe for consumption

• Purity - Ensuring food is free from adulteration

• Quality - Ensuring food meets certain quality standards

• Legality - Ensuring food is produced and sold legally

• Transparency - Ensuring information about food is easily accessible to consumers

• Accountability - Holding food businesses accountable for their actions

There are various types of licensing such as driver's license, professional license, business license, etc.

• Driver's license: required to legally operate a motor vehicle

• Professional license: required to practice a certain profession such as doctor, lawyer, engineer, etc.

• Business license: required to legally operate a business

• Software license: grants permission to use a software product

• Music license: grants permission to use copyrighted music

• Patent license: grants permission to...read more

Regulatory Affairs involves ensuring compliance with laws and regulations in various industries.

• Regulatory Affairs is a field that deals with the development, implementation, and compliance of regulations and laws.

• It involves working closely with government agencies and regulatory bodies to ensure that products, processes, and practices meet legal requirements.

• Regulatory Affairs professionals are responsible for obtaining and maintaining necessary licenses, permits, and appro...read more

Medical device regulatory bodies in India oversee the approval and monitoring of medical devices in the country.

• Central Drugs Standard Control Organization (CDSCO) is the primary regulatory body for medical devices in India

• Medical Device Rules, 2017 govern the registration and approval process for medical devices

• Indian Council of Medical Research (ICMR) also plays a role in regulating medical devices in India

Variation guidelines are regulatory requirements for making changes to a product's marketing authorization.

• Variation guidelines outline the procedures and documentation required for submitting changes to a product's marketing authorization.

• Changes can include modifications to the manufacturing process, formulation, packaging, labeling, or indications for use.

• Variation guidelines help ensure that changes do not compromise the safety, efficacy, or quality of the product.

• Regulat...read more

IP can refer to intellectual property, internet protocol, or intraperitoneal in medical field.

• Intellectual property (patents, trademarks, copyrights)

• Internet Protocol (IP) addresses for devices on a network

• Intraperitoneal (IP) administration of drugs in medical field

Windsor Framework is a dependency injection container for .NET applications.

• Windsor Framework is used for managing the dependencies of various components in a .NET application.

• It allows for easier testing and maintenance by decoupling components.

• Examples of other popular dependency injection containers include Unity, Autofac, and Ninject.

Different regulatory bodies are responsible for ensuring compliance with laws and regulations in various industries.

• Regulatory bodies vary by industry and country

• Examples include FDA for pharmaceuticals in the US, EMA for Europe, and EPA for environmental regulations

• Regulatory bodies set standards and guidelines for safety, efficacy, and quality

• Compliance with regulations is necessary for market approval and continued operation

Impurities are substances that are present in a chemical compound or mixture but are not the desired product.

• Impurities can affect the quality, safety, and efficacy of a product.

• They can be introduced during the manufacturing process or from external sources.

• Examples of impurities include residual solvents, heavy metals, and degradation products.

• Regulatory agencies have strict guidelines on acceptable levels of impurities in pharmaceutical products.