Biocon Regulatory Affairs Executive Interview: Rounds, Questions and Preparation

What the job involves

Regulatory Affairs Executives in pharma ensure that drugs, biologics, and medical devices comply with Indian and international regulations before they can be approved and marketed. They prepare and submit dossiers to authorities like CDSCO and FDA, track regulatory changes, and coordinate with R&D, manufacturing, and legal teams to maintain compliance. Day to day, they review documents, manage timelines, and respond to queries from regulators.

Role and Technical Knowledge

1. 1

   What is the difference between a New Drug Application (NDA) and an Abbreviated New Drug Application (ANDA)?

   Explain that NDA is for new drugs with full safety and efficacy data, while ANDA is for generics referencing an existing drug, requiring bioequivalence studies but not full clinical trials.

2. 2

   What are the key components of a Common Technical Document (CTD) as per ICH?

   Cover the five modules: administrative, quality, nonclinical, clinical, and regional. Mention that Module 1 is region-specific and others are common.

3. 3

   How does the Drugs and Cosmetics Act regulate the import and manufacture of drugs in India?

   Highlight that the Act sets standards for quality, safety, and efficacy; requires licenses for manufacture and import; and empowers CDSCO to approve and inspect.

4. 4

   What is the role of CDSCO in drug approval in India?

   Describe CDSCO as the national regulatory authority that evaluates applications, grants approvals, conducts inspections, and monitors adverse events.

Practical Scenarios

1. 5

   You are preparing a dossier for a new drug submission, and you notice that a key preclinical study report is missing. What do you do?

   Show that you would immediately inform your supervisor, coordinate with the R&D team to locate or repeat the study, and assess if the submission timeline can be adjusted without compromising compliance.

2. 6

   A regulatory authority sends a query about a discrepancy in your submitted stability data. How do you handle it?

   Explain that you would verify the data, consult with the analytical team, prepare a clear response with supporting documents, and submit within the deadline while maintaining a record.

3. 7

   Your company wants to export a drug to the EU, but the product does not meet EU GMP requirements. What steps would you take?

   Outline that you would conduct a gap analysis, work with manufacturing to upgrade processes, arrange for an EU GMP inspection, and update the dossier accordingly.

4. 8

   How would you prioritize your tasks if you have multiple submissions with overlapping deadlines?

   Mention assessing regulatory deadlines, risk of delays, and business impact; communicating with stakeholders; and using tools like trackers to manage timelines.

Behavioural and HR

1. 9

   Why do you want to work in regulatory affairs, and why at a company like Biocon?

   Connect your interest in ensuring patient safety and compliance with Biocon's reputation in biopharmaceuticals and its global regulatory footprint.

2. 10

   Describe a time when you had to work under pressure to meet a deadline.

   Use a specific example from academics or internships, highlighting planning, focus, and successful outcome.

3. 11

   How do you handle criticism or feedback on your work?

   Show openness to feedback, willingness to learn, and examples of improving based on input.

4. 12

   Where do you see yourself in five years in the regulatory field?

   Express a desire to deepen regulatory expertise, take on larger submissions, and possibly lead a team or specialize in a region.

Company and Sector Awareness

1. 13

   What do you know about Biocon's product portfolio and its regulatory milestones?

   Mention Biocon's focus on biologics, biosimilars, and small molecules; its approvals in India, US, and EU; and partnerships like with Mylan.

2. 14

   What are some recent changes in Indian pharmaceutical regulations that impact regulatory affairs?

   Discuss updates like the New Drugs and Clinical Trials Rules 2019, eCTD mandatory submission, and increased focus on pharmacovigilance.

3. 15

   How does regulatory affairs contribute to a company's business goals?

   Explain that it enables market access, ensures compliance to avoid penalties, and supports product lifecycle management from development to post-marketing.

4. 16

   What is the difference between regulatory affairs and quality assurance?

   Clarify that regulatory affairs focuses on submissions and interactions with authorities, while QA ensures internal processes meet quality standards and GMP.