Regulatory Affairs Specialist - Romania
We are hiring a regulatory Affairs role and looking for individual contributor who is fully proficient in applying regulatory Affairs knowledge for a
- established and marketed portfolio of pharmaceuticals and biologicals and can work with high sense of ownership under limited supervision.
Essential Functions Regulatory Role
CTD submissions), as appropriate; follow through post approval commitments.
- established marketed products in Medical device, pharmaceutical and Biological innovative products in, Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing/ Complex cross country change assessments/Market authorization approvals/ Gap analysis and assessments safety variations and manufacturing site renewals or as applicable.
- functional teams in additional to maximize external networking with potential clients and stakeholders to identify potential opportunity and bring more business.
Qualifications
- trainings, work easily on Veeva and collaborate according to ways of work
- market authorization.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
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