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

What the job involves

A Regulatory Affairs Executive in healthcare and pharma ensures that diagnostic kits, medical devices, and laboratory services comply with Indian and international regulations. Day to day, they prepare and submit dossiers to CDSCO, maintain licenses, track regulatory changes, and coordinate with quality and clinical teams. At a diagnostics company like Vijaya Diagnostics, this includes obtaining approvals for new test menus, renewing lab accreditations, and ensuring labeling and advertising compliance.

Role and Technical Knowledge

1. 1

   What are the key steps to obtain a manufacturing license for an in vitro diagnostic kit in India?

   Mention application to state licensing authority, submission of Form 24/24A, site inspection, and compliance with Schedule M-III. Highlight the role of CDSCO for import or central license.

2. 2

   Explain the difference between CDSCO and state FDA in the context of diagnostics regulation.

   CDSCO handles national approvals, imports, and clinical trials, while state FDA issues manufacturing and sales licenses. Show awareness that diagnostics often need both.

3. 3

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

   Cover product description, analytical validation, stability data, labeling, and manufacturing details. Mention CTD or ACTD format and the need for GMP certificates.

4. 4

   How do NABL and CAP accreditation differ for a diagnostics lab?

   NABL is the Indian accreditation body under ISO 15189, while CAP is international from the College of American Pathologists. Note that both require periodic audits and quality documentation.

Practical Scenarios

1. 5

   You discover that a recently launched test kit has a labeling error that could mislead clinicians. What do you do?

   Show a step-by-step approach: assess risk, inform quality and regulatory head, initiate recall or correction, report to CDSCO if needed, and document corrective actions. Emphasize patient safety and transparency.

2. 6

   A new regulation reduces the turnaround time for reporting adverse events from 15 days to 7 days. How would you update your processes?

   Describe revising SOPs, training staff, updating tracking systems, and communicating with partners. Mention the importance of a gap analysis and mock drills.

3. 7

   Your company wants to export a diagnostic kit to a country with different regulatory requirements. How would you prepare?

   Outline researching the target country's rules, gap assessment against current dossier, preparing additional data, and engaging local agents. Highlight WHO prequalification if relevant.

4. 8

   During an audit, you find that some training records are missing. How do you handle it?

   Acknowledge the finding, commit to immediate corrective action, reconstruct records if possible, and implement a tracker. Stress that audits are opportunities to improve systems.

Behavioural and HR

1. 9

   Tell us about a time you had to follow a rule you disagreed with. How did you handle it?

   Use a STAR example showing respect for compliance while voicing concerns through proper channels. Emphasize that in regulatory roles, rules protect patients.

2. 10

   How do you prioritize when you have multiple deadlines for license renewals and submissions?

   Explain a method like urgency vs. importance, regulatory due dates, and impact on operations. Mention communicating with stakeholders and using checklists.

3. 11

   Why do you want to work in regulatory affairs, and why in diagnostics?

   Connect personal interest in healthcare, attention to detail, and the growing importance of accurate diagnostics. Show awareness of the sector's role in public health.

4. 12

   Describe a situation where you had to explain a complex regulation to a non-expert colleague.

   Give an example of simplifying without losing accuracy, using analogies or step-by-step explanations. Highlight patience and clarity.

Company and Sector Awareness

1. 13

   What do you know about the regulatory challenges specific to a diagnostics chain like Vijaya Diagnostics?

   Mention multi-location licensing, varying state rules, NABL audits, and the need for consistent quality across centers. Avoid claiming specific internal practices.

2. 14

   How does the Drugs and Cosmetics Act apply to diagnostic reagents and kits?

   Explain that IVDs are regulated under the Act and Medical Device Rules, 2017, with classifications A to D. Mention that some reagents need import licenses and clinical performance evaluation.

3. 15

   What recent regulatory change in Indian healthcare could impact diagnostics companies?

   Discuss updates like the new IVD regulatory framework, eCTD implementation, or increased scrutiny on advertising. Show you follow CDSCO circulars and industry news.

4. 16

   Why is post-market surveillance important for diagnostic products?

   Highlight that it detects performance issues, ensures ongoing safety, and is mandatory for regulatory compliance. Mention adverse event reporting and periodic safety update reports.