Looking to advance your career in Regulatory Affairs and Regulatory Operations? A leading pharmaceutical organization is hiring for the role of Associate Regulatory Operations at its Mumbai Development Center (EPD division). This is a high-impact opportunity for professionals with 5+ years of regulatory experience to work on global submissions, dossier management, and document operations.

📌 Job Overview

• Role: Associate Regulatory Operations
• Location: Mumbai, India
• Experience: Minimum 5 years
• Qualification: Bachelor’s in Pharmacy / Life Sciences
• Application Deadline: April 18, 2026
• Job Type: Full-time

🚀 Key Responsibilities

As an Associate Regulatory Operations professional, you will:

• Manage and maintain documents in Document Management Systems (DMS)
• Handle workflow management and version control of regulatory documents
• Format documents using MS Word styles and submission standards
• Prepare PDF submission-ready documents using ISI Toolbox tools
• Perform quality checks (QC) from a formatting and compliance perspective
• Compile regulatory submissions into submission-ready binders
• Support non-eCTD dossier structures for global markets
• Coordinate with cross-functional teams (CMC, affiliates, global RA teams)
• Maintain trackers and generate monthly reporting data
• Train new users on systems like DARIUS
• Identify risks, suggest process improvements, and ensure timely delivery

🎯 Required Qualifications

• Bachelor’s degree in:
  • Pharmacy
  • Biology
  • Chemistry
  • Pharmacology or related field
• Minimum 5 years experience in:
  • Regulatory Affairs
  • Regulatory Operations
  • R&D or Manufacturing
• Strong expertise in:
  • Dossier management & submission compilation
  • Document formatting & publishing tools
  • Regulatory systems like DARIUS
  • Global regulatory workflows (especially non-eCTD regions)

💼 Core Skills & Competencies

• Regulatory submission lifecycle knowledge
• Attention to detail in document quality control
• Cross-functional collaboration
• Strong time management & deadline adherence
• Risk identification and mitigation
• Process improvement mindset

💰 Salary & Benefits

• Estimated Salary: ₹10,00,000 – ₹18,00,000 per annum
• Exposure to global regulatory operations
• Opportunity to work with international stakeholders
• Career growth in Regulatory Affairs domain
• Stable full-time corporate role

📥 How to Apply

Application Link