Associate Regulatory Affairs Lead Interview Questions and Answers

CMC variations refer to changes made to the chemistry, manufacturing, and controls of a drug product.

• CMC variations are submitted to regulatory agencies to ensure that changes made to a drug product do not affect its safety, efficacy, or quality.

• Types of CMC variations include minor, moderate, and major changes, each with different requirements for submission and approval.

• Examples of CMC variations include changes to the manufacturing process, raw materials, or specifications...read more

EU has various types of variations and guidelines for regulatory affairs.

• Types of variations include Type IA, Type IB, Type II, and Type II variations with extension

• Guidelines include the Variation Regulation (EC) No 1234/2008 and the Variation Guidelines

• Type IA variations are minor changes that do not require prior approval

• Type IB variations are moderate changes that require prior approval

• Type II variations are major changes that require prior approval and assessment by regu...read more

CTD modules are a set of documents required for regulatory submission of drugs.

• Module 1: Administrative and prescribing information

• Module 2: Common Technical Document Summaries

• Module 3: Quality

• Module 4: Nonclinical Study Reports

• Module 5: Clinical Study Reports