GSK India Regulatory Affairs Executive Interview: Rounds, Questions and Preparation

What the job involves

Regulatory Affairs Executives ensure that pharmaceutical products comply with Indian and international regulations before they can be manufactured, tested, and sold. They prepare and submit dossiers to authorities like CDSCO for domestic approvals and to agencies like US FDA or EMA for global markets, and they manage lifecycle changes, labelling, and post-approval commitments. Day to day work involves document review, cross-functional coordination with R&D, quality, and manufacturing, and keeping up with changing guidelines.

Role and technical knowledge

1. 1

   What is the difference between CDSCO and state licensing authorities in India?

   Explain that CDSCO is the central drug regulator for approvals of new drugs, imports, and clinical trials, while state authorities handle manufacturing and sale licences. Mention that both work under the Drugs and Cosmetics Act.

2. 2

   What are the key modules of a CTD dossier and what goes into Module 3?

   List the five CTD modules: 1 Administrative, 2 Summaries, 3 Quality, 4 Nonclinical, 5 Clinical. For Module 3, mention drug substance and drug product data, manufacturing process, controls, and stability.

3. 3

   What is the role of ICH guidelines in regulatory submissions?

   Say that ICH harmonises technical requirements across regions, making dossiers acceptable in multiple countries. Give examples like Q1 stability, Q7 GMP, and E6 GCP.

4. 4

   How would you handle a situation where a required stability study is missing from a dossier?

   Show that you would first check if an alternative source or commitment is possible, then inform the team and assess timeline impact. Emphasise transparent communication with the authority if needed.

Practical scenarios

1. 5

   You notice a typo in the product label after the artwork has been approved. What do you do?

   Say you would immediately flag it to your supervisor, assess if it is a critical error, and follow the change control process. Mention documenting the correction and preventing recurrence.

2. 6

   A regulatory deadline is approaching, but you are waiting for data from the R&D team. How do you manage this?

   Explain that you would escalate early, propose a partial submission if allowed, and keep a clear audit trail of follow-ups. Highlight prioritisation and stakeholder communication.

3. 7

   How would you respond if an inspector asks for a document that is not in the current filing?

   Show that you would stay calm, acknowledge the request, and commit to providing it within the agreed timeframe. Mention that you would not guess or provide unverified information.

4. 8

   You are asked to submit a dossier in eCTD format for the first time. How do you prepare?

   Talk about reviewing the eCTD specification, using validated software, and doing a mock submission. Mention checking regional requirements and getting a senior review before filing.

Behavioural and teamwork

1. 9

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

   Use a STAR example from college projects or internships. Focus on how you prioritised tasks, communicated gaps, and still delivered a usable output.

2. 10

   Describe a situation where you disagreed with a teammate on a document change. How did you resolve it?

   Show that you listened, referred to guidelines or data, and escalated if needed. Emphasise that the goal is compliance and patient safety, not winning the argument.

3. 11

   How do you keep yourself updated on changing regulations?

   Mention following CDSCO and ICH websites, regulatory newsletters, and internal training. Give a recent example of a guideline change you read about.

HR and motivation

1. 12

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

   Connect your interest in compliance, documentation, and global health impact. Show that you understand the role is detail-oriented and cross-functional.

2. 13

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

   Talk about gaining depth in one therapeutic area or region, taking ownership of submissions, and possibly mentoring juniors. Avoid vague answers like 'manager' without context.

3. 14

   How would you handle a situation where you are asked to do something that violates a regulatory guideline?

   State clearly that you would refuse and report it through the proper channel. Emphasise that patient safety and integrity come first, and that you would seek guidance from a senior.

4. 15

   What do you know about our company's therapy areas and regulatory footprint?

   Research the company's key products, major markets, and recent approvals. Mention how regulatory affairs supports launches in India and abroad.