
Dr. Mihai Joiteanu
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Mihai Joiteanu
- Bis heute 11 Jahre und 5 Monate, seit Jan. 2014
Regulatory Affairs Consultant
Consultant
Translations of PiL documents (SPC, leaflet, labelling); Filling application for for new submissions, renewals, variations, line extensions; Providing necessary support for submmisions (new sumbmissions, renewals, varations, line extensions)
- 8 Jahre und 8 Monate, Mai 2005 - Dez. 2013
Regulatory Affairs Manager and QP for Pharmacovigilance
Ceva Sante Animale Romania
Building & validating/ensuring dossiers compliance with legislation and local requirements. Submissions for new MA, renewals, variations and line extension. Maintenance and compliance of existing Marketing Authorizations. Keep up-to date the latest regulatory requirements. Proposing necessary budget. QA responsible as Subsidiary Responsible Veterinarian. QP for PhV.
- 9 Monate, Sep. 2004 - Mai 2005
Country Coordinator
Greenpoint Trade Bucarest
Organization and coordination of a national distribution network. Establishing, developing and managing of business relations with suppliers and customers. Import formalities and custom clearance for all imported goods. Marketing and sales of VMP. Consultancy for end-users. Permanent acknowledgement of the VMP market.
- 1 Jahr und 1 Monat, Sep. 2003 - Sep. 2004
Brand Manager
Biopet Trading Bucharest
Consultancy for farmers and veterinarians. Marketing and sales of VMP. Constant information about VMP market. Establishing, developing and managing of business relations with suppliers and customers. Performing market studies for new products. Import formalities and custom clearance for all imported goods.
- 3 Jahre und 4 Monate, Juni 2000 - Sep. 2003
Regulatory Affairs Manager & Logistic Manager
Delos Impex 96 Bucharest
Building dossiers according with local legislation/requirements. Submissions for new MA, renewals and variations. Validating PL (SPC, leaflet, labeling, promotional materials). Keeping a permanent contact with Regulatory Authorities. Maintenance and compliance of existing Marketing Authorizations. Keeping up-to date with latest national regulatory requirements. Proposing the necessary budget for R&D.
Ausbildung von Mihai Joiteanu
- 5 Jahre und 9 Monate, Okt. 1993 - Juni 1999
Veterinary Medicine
Faculty of Veterinary Medicine, USAMV Bucharest
Sprachen
Englisch
Fließend
Französisch
Gut
Italienisch
Gut
Spanisch
Gut
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