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4 anos de experiencia

Competencias

CTD Dossier Preparation Regulatory Affairs Compliance Product Registration Pharmacovigilance Regulatory Intelligence GMP GCP Stakeholder Liaison Authority Liaison Adverse Drug Reaction Reporting SOP Management Regulatory Submission Dossier Management Regulatory Liaison

Experiencia

Pharmacist -Regulatory affairs

ALCHEM Industries

2021-10 - ui.present

* Manage the preparation, review, and submission of regulatory dossiers for product registrations, renewals, and variations. * Liaise with ABREMA and international manufacturers to ensure compliance with regulatory requirements and timely product approvals. * Maintain regulatory documentation and provide regulatory support to cross-functional teams. * Successfully submitted over 200 regulatory dossiers and contributed to obtaining 100+marketing authorizations for pharmaceutical products in Burundi.

Formacion

Bachelor of Science in Pharmacy, Jiangsu University, 2016-2020

Idiomas

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