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
