Sakra World Hospital Regulatory Affairs Executive Interview: Rounds, Questions and Preparation

What the job involves

A Regulatory Affairs Executive in a hospital or pharma company ensures that products, clinical services, and documentation comply with Indian and international regulations. Day to day, you prepare and submit dossiers to authorities like CDSCO, maintain regulatory files, track changes in law, and support audits and inspections. In a fast-growing hospital like Sakra World Hospital, you might also handle licensing for new departments, medical devices, and clinical trial approvals.

Role and Technical Knowledge

1. 1

   What is the difference between CDSCO and state FDA in drug approval?

   Explain that CDSCO is the central authority for new drugs, imports, and clinical trials, while state FDA handles manufacturing licences, sales licences, and routine inspections. Mention coordination between them.

2. 2

   What documents are typically part of a regulatory dossier for a new drug in India?

   Cover Module 1 (administrative), Module 2 (summaries), Module 3 (quality), Module 4 (nonclinical), Module 5 (clinical). Mention Form 44, TR6 challan, and undertaking for BA/BE studies.

3. 3

   How does the Drugs and Cosmetics Act classify medical devices?

   Explain risk-based classes A, B, C, D under Medical Device Rules 2017. Mention examples like thermometers (A), syringes (B), implants (C), and heart valves (D).

4. 4

   What is the role of a regulatory affairs executive in pharmacovigilance?

   Describe collecting adverse event reports, submitting them to CDSCO or PvPI within timelines, maintaining a safety database, and supporting signal detection.

Practical Scenarios

1. 5

   You are preparing for a CDSCO audit at your hospital. What steps do you take in the week before?

   Mention reviewing all licences, training records, equipment calibration logs, and previous audit observations. Ensure staff are briefed and documents are organised in a traceable manner.

2. 6

   A new regulation reduces the timeline for reporting a serious adverse event. How do you update your process?

   Explain revising SOPs, training the team, updating the safety database, and communicating the change to relevant departments. Emphasise quick implementation and documentation.

3. 7

   You find an error in a submitted dossier after submission. What do you do?

   Say you would immediately inform your manager, assess the impact, and prepare a correction or addendum to submit to the authority. Highlight transparency and not hiding mistakes.

4. 8

   A hospital wants to import a medical device not yet approved in India. How would you proceed?

   Mention applying for import licence under Form 8 or 9, providing clinical justification, and obtaining CDSCO approval. Note that unapproved devices may need special access approval.

Behavioural and HR

1. 9

   Tell me about a time you had to meet a strict deadline with incomplete information.

   Use STAR method: describe the situation, the action you took to gather what you could, and the outcome. Show you can prioritise and communicate risks.

2. 10

   Why do you want to work in regulatory affairs rather than clinical or marketing roles?

   Connect your interest in compliance, law, and patient safety. Mention enjoying detail-oriented work and wanting to ensure products are safe and legally approved.

3. 11

   How do you handle a senior doctor who insists on using an unapproved drug for a patient?

   Show respect but firmness: explain the regulatory and ethical risks, suggest alternative approved options, and escalate to the ethics committee or medical director if needed.

4. 12

   Where do you see yourself in three years in regulatory affairs?

   Express desire to deepen expertise in Indian and global regulations, possibly take on more complex submissions, and mentor juniors. Avoid saying you want to leave the field.

Company and Sector Awareness

1. 13

   What do you know about Sakra World Hospital and its regulatory needs?

   Mention it is a multi-specialty hospital in Bangalore with focus on advanced treatments. Note that hospitals need licences for drugs, devices, blood bank, and clinical trials, plus compliance with NABH and other standards.

2. 14

   How does NABH accreditation affect regulatory affairs in a hospital?

   Explain that NABH requires documented policies, patient safety protocols, and regular audits. Regulatory affairs helps maintain records and ensure compliance during NABH assessments.

3. 15

   What recent change in Indian pharma regulation do you think is important?

   You could mention the new Drugs and Clinical Trials Rules 2019, e-pharmacy regulations, or the push for digital submissions. Show you follow updates from CDSCO.

4. 16

   Why should a hospital invest in a strong regulatory affairs team?

   Highlight avoiding legal penalties, ensuring patient safety, enabling faster approvals for new services, and protecting the hospital's reputation. Mention that non-compliance can lead to licence cancellation.