Drug regulatory affairs interview preparation

What is regulatory affairs?
Regulatory affairs is a profession that ensures compliance with regulations governing the development, approval, and marketing of medical products such as drugs, biologics, and medical devices. It acts as a bridge between regulatory authorities and companies.

Why is regulatory affairs important?
It ensures that medical products are safe, effective, and meet all legal requirements before reaching the market. Regulatory affairs also facilitate timely approvals and ensure post-market surveillance to maintain safety.

What is a Common Technical Document (CTD)?
The CTD is a standardized format for regulatory submissions, consisting of five modules:

• Module 1: Regional information.

• Module 2: Overview and summaries of quality, nonclinical, and clinical data.

• Module 3: Quality (pharmaceutical data).

• Module 4: Nonclinical study reports.

• Module 5: Clinical study reports.

What is the difference between NDA, ANDA, and IND?

• NDA (New Drug Application): Submitted for approval of a new drug.

• ANDA (Abbreviated New Drug Application): Filed for generic drug approval.

• IND (Investigational New Drug Application): Submitted to seek approval for clinical trials.

What are some key regulatory authorities worldwide?

• USFDA: United States Food and Drug Administration.

• EMA: European Medicines Agency.

• CDSCO: Central Drugs Standard Control Organization (India).

• MHRA: Medicines and Healthcare products Regulatory Agency (UK).

• TGA: Therapeutic Goods Administration (Australia).

• PMDA: Pharmaceuticals and Medical Devices Agency (Japan).

What are ICH guidelines?
ICH (International Council for Harmonisation) guidelines provide a unified approach to drug development and regulatory submissions to ensure quality, safety, and efficacy. Examples include:

• ICH Q1-Q10: Quality guidelines.

• ICH E6: Good Clinical Practice (GCP).

• ICH M4: CTD guidelines.

What is Good Manufacturing Practice (GMP)?
GMP ensures that products are consistently produced and controlled to meet quality standards appropriate for their intended use and comply with regulatory requirements.

What is the Drug Master File (DMF)?
A DMF is a confidential submission to the regulatory authority that provides detailed information about facilities, processes, and materials used in the manufacturing of a drug.

What is the difference between pre-approval and post-approval submissions?

• Pre-approval submissions: Include INDs, NDAs, and CTDs, required to gain approval for clinical trials or marketing.

• Post-approval submissions: Include variations, supplements, and renewals, needed to maintain compliance after a product is on the market.

What is the 510(k) submission process?
The 510(k) is a premarket submission made to the FDA to demonstrate that a medical device is substantially equivalent to a legally marketed device.

What is a CEP?
A Certificate of Suitability (CEP) certifies that an active substance complies with European Pharmacopeia standards, simplifying regulatory submissions in the EU.

What are variations in regulatory terms?
Variations are changes to an approved product, such as modifications to its formulation, manufacturing process, or packaging. They are categorized as major, moderate, or minor based on their impact.

What are the responsibilities of a regulatory affairs associate?

• Preparing and submitting regulatory documents.

• Ensuring compliance with guidelines and regulations.

• Communicating with regulatory authorities.

• Assisting in audits and inspections.

• Monitoring regulatory updates.

How do you ensure regulatory compliance in submissions?
By following applicable guidelines (e.g., ICH, FDA, EMA), cross-checking data for accuracy, and maintaining up-to-date knowledge of regional regulations.

What skills are essential for success in regulatory affairs?

• Strong attention to detail.

• Knowledge of regulatory guidelines and processes.

• Effective communication and writing skills.

• Organizational skills to manage multiple submissions.

• Familiarity with tools like eCTD software.

What is eCTD?
The electronic Common Technical Document (eCTD) is a digital format for submitting regulatory information, simplifying data review and facilitating approvals.

What tools are commonly used in regulatory affairs?

• eCTD software (e.g., Lorenz DocuBridge, Extedo).

• Regulatory tracking tools.

• Document management systems like Veeva Vault.

What is a lifecycle management system in regulatory affairs?
Lifecycle management involves tracking and maintaining the compliance of a product throughout its market life, including post-approval variations, renewals, and safety updates.

What is the difference between biosimilars and generics?

• Biosimilars: Biologically similar to a reference biologic product but not identical.

• Generics: Identical to the reference drug in terms of active ingredients, dosage, and strength.

What is orphan drug designation?
Orphan drug designation is granted to drugs intended to treat rare diseases affecting a small population, offering benefits like market exclusivity and tax incentives.

What are Good Regulatory Practices (GRP)?
GRP refers to principles and practices aimed at enhancing regulatory quality and efficiency, ensuring transparent and science-based decision-making.

What challenges do regulatory professionals face?

• Keeping up with frequent regulatory updates.

• Handling complex submission requirements for global markets.

• Ensuring timely approvals while maintaining compliance.