Krsnaa Diagnostics Regulatory Affairs Executive Interview: Rounds, Questions and Preparation

What the job involves

A Regulatory Affairs Executive in diagnostics and pharma ensures that products, tests, and facilities comply with Indian and international regulations. Day to day, this involves preparing and submitting dossiers to regulators like CDSCO, maintaining licences, tracking regulatory changes, and supporting audits and quality teams. At a diagnostics company such as Krsnaa Diagnostics, the role often focuses on lab accreditation, test kit approvals, and ensuring compliance with NABL and ICMR guidelines.

Role and Technical Knowledge

1. 1

   What is the role of CDSCO in regulating in-vitro diagnostic kits in India?

   Explain that CDSCO approves and monitors IVDs under the Medical Devices Rules, 2017, and that kits need registration or licences before sale. Mention risk-based classification and the Central Licensing Authority.

2. 2

   What is the difference between NABL accreditation and ICMR approval for a diagnostic lab?

   NABL accredits labs for quality and competence under ISO 15189, while ICMR approves labs for specific tests or research. Both are important for credibility and government tie-ups.

3. 3

   What documents are typically part of a regulatory dossier for a new diagnostic test?

   Cover product details, manufacturing information, performance evaluation data, stability studies, labelling, and proposed claims. Mention the need for a covering letter and fees.

4. 4

   How do you keep track of changing regulatory requirements in Indian healthcare?

   Mention official sources like CDSCO and NABL websites, gazette notifications, industry newsletters, and internal regulatory intelligence systems. Show a habit of regular review.

Practical Scenarios

1. 5

   A diagnostic kit you are about to submit lacks stability data for one parameter. What do you do?

   Say you would not submit incomplete data. You would coordinate with R&D to generate missing data, document the gap, and set a realistic timeline. Escalate if it risks a deadline.

2. 6

   You notice a discrepancy in a lab's SOP versus actual practice during an internal audit. How do you handle it?

   Describe documenting the observation, discussing with the lab head, and proposing a corrective action. Emphasise not ignoring it and following the CAPA process.

3. 7

   A new regulation reduces the shelf life allowed for a test kit you already sell. What steps do you take?

   Outline impact assessment, updating labels and dossiers, informing distributors, and seeking timelines from the regulator. Mention risk communication and stock management.

4. 8

   You need to submit a dossier in two weeks but are waiting on data from a partner lab. How do you manage?

   Talk about prioritising sections, following up daily, using a tracker, and preparing a partial submission if allowed. Show proactive communication with all stakeholders.

Behavioural and HR

1. 9

   Why do you want to work in regulatory affairs rather than in a lab or research role?

   Show interest in compliance, documentation, and the bigger picture of patient safety. Link it to your strengths in detail and organisation.

2. 10

   Tell me about a time you had to follow a rule you disagreed with.

   Pick a real example from college or internship. Explain you understood the rationale, followed it, and raised concerns through proper channels if needed.

3. 11

   How do you handle tight deadlines and repetitive documentation work?

   Mention checklists, time blocking, and focus on accuracy. Show you understand that regulatory work requires patience and precision.

4. 12

   Where do you see yourself in three years in this field?

   Talk about growing into a senior regulatory role, learning international submissions, and contributing to audits. Keep it realistic and aligned with the company.

Company and Sector Awareness

1. 13

   What do you know about Krsnaa Diagnostics and its business model?

   Mention it is a leading diagnostic chain with a focus on affordable and accessible testing, often through public-private partnerships. Highlight its pan-India presence and radiology plus pathology services.

2. 14

   Why is regulatory compliance especially important for a diagnostics company?

   Explain that accurate results depend on validated kits, trained staff, and accredited processes. Non-compliance can harm patients, lead to legal action, and damage trust.

3. 15

   How does a regulatory affairs executive support a company's growth?

   By enabling faster approvals, ensuring smooth audits, and preventing penalties. Show that good regulatory work is a business enabler, not just a cost.

4. 16

   What recent change in Indian healthcare regulation do you think affects diagnostic companies?

   You can mention the Medical Devices Rules amendments, NABL's stricter norms, or ICMR guidelines on testing. Show you read news and understand its impact.