Manager - 2

SUN PHARMA

📍Vadodara, Gujarat, India
Posted May 21, 2026
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Job Overview

Position

Manager - 2

Company

SUN PHARMA

Location

Vadodara, Gujarat, India

Work Type

On-site

Job ID

li-4302368406

Job Description

Executive and Sr. Executive

  • Review all data and documents related to product registrations for various health authorities.

  • Compile registration dossiers for submission to various health authorities like – China , Canada, Europe, Australia/New Zealand, Japan and Israel.

  • Prepare responses to deficiency letters received from various agencies.

  • Maintain life-cycle / post approval changes for drug product registration dossiers.

  • Provide regulatory support to cross functional departments.

  • Prepare and submit scientific advice to various health authorities.

  • eCTD compilation, verification and submission through electronic gateway
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Interview Prep

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Key Skills

Required:
Preferred:

Practice Questions

💡Technical Questions (3)
  • 1.Can you walk me through your process for compiling an eCTD dossier for a highly regulated market like Europe or Japan, and how you ensure the submission through the electronic gateway is error-free?
  • 2.When you receive a deficiency letter from a health authority like Health Canada or the PMDA in Japan, what is your strategy for preparing an effective and timely response?
  • 3.How do you manage the regulatory life-cycle and post-approval changes for a drug product dossier across multiple jurisdictions simultaneously?
🎯Behavioral Questions (3)
  • 1.Tell me about a time you had to provide regulatory support to a cross-functional department that was resistant to your requirements for a registration dossier.
  • 2.Describe a situation where you had to prepare a response to a complex deficiency letter under a tight deadline.
  • 3.Give an example of a time you successfully prepared and submitted a scientific advice request to a health authority to guide your development strategy.
🧩Situational Questions (2)
  • 1.You are reviewing data for a China NMPA submission and notice a discrepancy in the stability data provided by the QA department just days before the planned eCTD finalization. What do you do?
  • 2.You are managing post-approval changes for a product registered in both Europe and Australia. The change requires a Type II variation in Europe, but Australia requires a separate, different category of submission. How do you approach this?

Resume Keywords

Make sure these keywords appear on your resume

Regulatory AffairseCTDDossier CompilationDeficiency ResponsePost-Approval ChangesLife-Cycle ManagementScientific AdviceCross-Functional CollaborationGlobal Health AuthoritiesElectronic Gateway Submission

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