Bharat Biotech Regulatory Affairs Executive Interview: Rounds, Questions and Preparation

What the job involves

A Regulatory Affairs Executive in pharma helps prepare, compile, and submit dossiers to regulatory bodies like CDSCO and international agencies to get and keep drug or vaccine approvals. Day to day, you track submission timelines, review labelling and CMC documents for compliance, respond to queries from regulators, and maintain records for audits. At vaccine-focused companies such as Bharat Biotech, this often means working on both Indian and global filings for vaccines and biologics.

Role and technical knowledge

1. 1

   What is the difference between CDSCO and DCGI, and what does each do?

   Explain that CDSCO is the national regulatory authority and DCGI is its head who approves drugs, clinical trials, and imports. Mention state drug controllers for manufacturing licences.

2. 2

   What are the common sections of a CTD dossier?

   List Module 1 to Module 5: administrative, quality, non-clinical, clinical, and the regional or administrative module. Briefly say what each contains.

3. 3

   How does the approval pathway for a new vaccine differ from a new chemical drug in India?

   Mention that vaccines need preclinical and clinical data plus lot release and stability data, and may get accelerated approval in public health emergencies. Note CDSCO and sometimes ICMR involvement.

4. 4

   What is the role of ICH guidelines in regulatory submissions?

   Explain that ICH provides harmonised technical requirements for quality, safety, and efficacy, which many countries including India reference for dossiers and stability studies.

Practical scenarios

1. 5

   You find a discrepancy in the stability data of a batch before a submission deadline. What do you do?

   Say you would flag it immediately to your supervisor, verify the source, and not submit incorrect data. Mention documenting the issue and checking if the deadline can be extended or a clarification sought.

2. 6

   A regulator sends a query on your dossier two days before a holiday. How do you handle it?

   Show that you would prioritise the query, coordinate with cross-functional teams like QA and R&D, prepare a draft response, and keep your manager informed on feasibility.

3. 7

   How would you prepare a labelling artwork for a new vaccine indication?

   Mention checking approved indications, dosage, warnings, and local language requirements against the approved label, then routing it through QA and regulatory review before submission.

4. 8

   You need to submit documents to a foreign regulator but some data is missing. What steps do you take?

   Explain that you would list the missing items, request them from the relevant department, and check if a gap or justification can be included. Never submit incomplete data without approval.

Behavioural and situational questions

1. 9

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

   Use a STAR example from a project or internship. Highlight how you prioritised, communicated, and still maintained accuracy.

2. 10

   How do you handle a situation where a senior asks you to skip a regulatory check to save time?

   Say you would politely explain the compliance risk and suggest a faster but compliant alternative. Show you value patient safety and rules over speed.

3. 11

   Describe a time you found a mistake in your own work and corrected it.

   Pick a real example where you reviewed your work, spotted an error, and fixed it before submission. Emphasise attention to detail and honesty.

4. 12

   How do you keep yourself updated on changing regulatory requirements?

   Mention following CDSCO and WHO updates, reading industry newsletters, and noting changes in rules like the New Drugs and Clinical Trials Rules.

HR and motivation

1. 13

   Why do you want to work in regulatory affairs rather than in R&D or production?

   Talk about your interest in compliance, documentation, and the big picture of bringing a product to market. Link it to patient access and safety.

2. 14

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

   Show a realistic path such as moving from executive to senior executive, gaining expertise in global submissions, and possibly leading a small dossier team.

3. 15

   Are you comfortable working with strict deadlines and repetitive documentation?

   Say yes and give an example of how you stayed organised and accurate during a repetitive or deadline-driven task in college or an internship.

4. 16

   Why do you want to join a vaccine or biologics company like ours?

   Mention the public health impact of vaccines, the complexity of biologics regulation, and your interest in learning that specialised area.