Anca Bilea
Regulatory Affairs Manager Europe, Africa and CIS at Nordic Pharma- Claim this Profile
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Romanian Native or bilingual proficiency
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English Full professional proficiency
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French Limited working proficiency
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Bio
Experience
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Nordic Pharma
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France
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Regulatory Affairs Manager Europe, Africa and CIS
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Mar 2018 - Present
Manage regulatory activities across 24 territories within the CEE/CIS/AFRICA region.Foster regulatory knowledge and comprehend the evolving regulatory landscape.Oversee product marketing authorizations while maintaining communication with local authorities.Coordinate GMP inspections in CIS and African countries.Participate in RIM system implementation, contribute to promotional and educational materials.
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Regulatory Affairs Associate Europe, Africa and CIS
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Sep 2017 - Mar 2018
Managed registrations, renewals, and lifecycle management of generics and biosimilars in CIS and Africa.Coordinated GMP inspections in CIS and African countries.Maintained responsibility for the labeling of all portfolio registered in CIS, East Africa, and the EU.Reviewed and approved promotional materials, ensuring compliance.Participated in the revision of printed components and artworks for pharmaceutical packaging.
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Farmaciile DONA
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Romania
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Pharmacist Manager
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Sep 2014 - Sep 2017
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Tilia Farm SRL
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Galaţi, România
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Chief Pharmacist
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Mar 2013 - Aug 2014
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Salviafarm pharmacy
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Galaţi, România
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Chief Pharmacist
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Oct 2010 - Mar 2013
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Education
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Universitatea de Medicină și Farmacie „Carol Davila” din București
Pharmacist, Pharmacy -
Colegiul National Mihail Kogalniceanu, Galati
Matematică și informatică