Dr. Miran Javorovic

Angestellt, Regulatory Affairs Manager, PPD Germany GmbH & Co. KG
München, Germany

Fähigkeiten und Kenntnisse

Project Management
Clinical Trials
Regulatory Affairs
Regulatory Submissions
Regulatory Strategy
Molecular Biology
Immunology
Pharmaceutical Industry
CRO
Precision
Attention to detail
Articulate
Fluent in three languages
Strong presentation skills
Helpful
Team Player
Excel
PowerPoint
Photoshop
Database Design
Advanced Therapy Medicinal Products (ATMPs)
Cell-based therapies
Investigational Medicinal Products
Medicinal Product Development
Pharmaceutical Product Development
Outlook

Werdegang

Berufserfahrung von Miran Javorovic

  • Current 10 years and 2 months, since Apr 2016

    Regulatory Affairs Manager

    PPD Germany GmbH & Co. KG

    In addition to the below: line management; project oversight; process development and optimization

  • 2 years and 9 months, Jul 2013 - Mar 2016

    Principal Regulatory Affairs Specialist

    PPD Germany GmbH & Co. KG

    Management of processes and employees working on regulatory submissions of "Clinical Trial Applications" for large, multinational trials with chemicals and bio(techno)logicals in 35+ countries per trial

  • 1 year and 3 months, Apr 2012 - Jun 2013

    Senior Regulatory Affairs Specialist

    PPD Germany GmbH & Co. KG

    Management of regulatory submissions of "Clinical Trial Applications" for trials with chemicals and bio(techno)logicals in Austria, Germany and Switzerland

  • 2 years and 6 months, Oct 2009 - Mar 2012

    Regulatory Affairs Manager

    Klinikum der Universität München

    Medical and scientific writing, and preparation of a "Clinical Trial Application" for a phase-I investigator-initiated trial with a cell-based vaccine against leukemia

  • 1 year and 8 months, Jan 2008 - Aug 2009

    Associate Consultant

    McKinsey & Company, Inc.

    Management consulting on projects with leaderships of large international pharmaceutical/biotech companies focusing on market-access/regulatory-affairs, marketing and sales strategies and their implementation in major European

  • 3 years and 11 months, Feb 2004 - Dec 2007

    Postdoctoral Fellow

    Helmholtz Zentrum München (ex-GSF)

    Development of cell-based therapy against renal cancer

Ausbildung von Miran Javorovic

  • 3 years and 7 months, Jul 2000 - Jan 2004

    Molecular Immunology

    Ludwig-Maximilians-Universität, Munich, Germany

  • 4 years and 9 months, Oct 1995 - Jun 2000

    Molecular Biology

    Zagreber Universität, Zagreb, Kroatien

Sprachen

  • German

    C1 (Fließend)

  • English

    C1 (Fließend)

  • French

    B1-B2 (Gute Kenntnisse)

  • Coratian first language

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