M
Medipharma Konnect
Regulatory affairs Professional
Skills
Testing & QARCompliance
3 months ago
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Important information
Contract type:
Permanent
Location:
Ahmedabad, Gujarat, India
Work mode:
Onsite
Published on:
10 August 2026
What they need
- 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
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