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Vector HR
Regulatory Affairs
Vector HR · posted 6 months ago
Ahmedabadoperations
About the role
Job Position : Manager - Regulatory Affairs ( 2 Positions)
Job Locations – Head Office (Ahmadabad)
Key roles:
- Deep knowledge of CTD dossier submission formats, and regional requirements
- Review & submission of the product dossiers as per regulatory guidelines
- Timely submission of query response
- Manage post-approval activities, including variations, renewals for marketed products
- Documents review as per country-specific guidelines
- Work experience in ROW - ASEAN/AFRICA/LATAM/CIS
- Collaborate with CFT for regulatory expectations
Job Position : Assistant Manager - Regulatory Affairs ( 3 Positions)
Job Location – Sanand GIDC (Plant)
Key roles:
- Review of the product dossiers as per regulatory guidelines
- Ability to evaluate the query and respond within timeline
- Review of Artworks and label as per market requirements
- Better understanding of ICH guidelines
- Documents review as per country-specific guidelines
- Work experience in ROW - ASEAN/AFRICA/LATAM/CIS
- Ability to coordinate with CFT for documentation
Company is 6 Days working.