Dr. Mihai Joiteanu

Selbstständig, Regulatory Affairs Consultant, Consultant
Auvernier, Switzerland

Fähigkeiten und Kenntnisse

Flexibility
Teamwork abilities
Quick learner
Attention to detail

Werdegang

Berufserfahrung von Mihai Joiteanu

  • Current 12 years and 5 months, since 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 years and 8 months, May 2005 - Dec 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 months, Sep 2004 - May 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 year and 1 month, 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 years and 4 months, Jun 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 years and 9 months, Oct 1993 - Jun 1999

    Veterinary Medicine

    Faculty of Veterinary Medicine, USAMV Bucharest

Sprachen

  • English

    C1 (Fließend)

  • French

    B1-B2 (Gute Kenntnisse)

  • Italian

    B1-B2 (Gute Kenntnisse)

  • Spanish

    B1-B2 (Gute Kenntnisse)

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