Drug Regulatory Affairs Officer Interview Questions and Answers

Regulatory affairs involves ensuring compliance with regulations and laws related to drugs and medical devices.

• Regulatory affairs officers work to ensure that drugs and medical devices meet regulatory requirements before they can be marketed or sold.

• They are responsible for submitting applications and obtaining approvals from regulatory agencies such as the FDA.

• They also monitor and report adverse events related to drugs and medical devices.

• Regulatory affairs officers must st...read more

Different stability conditions refer to various environmental factors that can affect the stability of a drug product.

• Temperature: Different temperature conditions such as room temperature, refrigerated, and frozen can impact the stability of a drug.

• Humidity: High humidity levels can lead to degradation of certain drugs.

• Light: Exposure to light, especially UV light, can cause degradation of photosensitive drugs.

• Oxygen: Oxygen can react with certain drugs leading to degradatio...read more

CTD stands for Common Technical Document, eCTD stands for electronic Common Technical Document, ICH guidelines are international standards for pharmaceutical development.

• CTD is a standardized format for submitting regulatory information to health authorities.

• eCTD is the electronic version of CTD, allowing for easier submission and review of regulatory documents.

• ICH guidelines are developed by the International Council for Harmonisation of Technical Requirements for Pharmaceut...read more

Regulatory affairs involves ensuring compliance with laws and regulations related to pharmaceuticals and medical devices.

• Regulatory affairs officers ensure that pharmaceuticals and medical devices meet safety and efficacy standards set by regulatory agencies.

• They are responsible for obtaining and maintaining regulatory approval for products.

• They also monitor and report adverse events related to products.

• Examples of regulatory agencies include the FDA, EMA, and MHRA.

• Regulatory...read more