- Preparation, compilation, and submission of regulatory dossiers (CTD/eCTD format)
- Handling product registration, renewals, and variations
- Coordination with regulatory authorities for approvals and queries
- Ensuring compliance with guidelines of authorities like Central Drugs Standard Control Organization (CDSCO), US Food and Drug Administration (USFDA), and European Medicines Agency (EMA)
- Reviewing and maintaining regulatory documentation
- Tracking submission timelines and approvals
- Liaising with cross-functional teams (QA, QC, Production, R&D;)
- Monitoring changes in regulatory guidelines and implementing updates
- Experience in international market registrations (CIS, Africa, LATAM, etc.)
- Exposure to lifecycle management and post-approval changes
- Familiarity with pharmacovigilance and labeling regulations
📌 Regulatory affairs Professional (Mumbai)
🏢 Medipharma Konnect
📍 Mumbai
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