Dr. Diana Radovan

Bis 2021, Associate Director Regulatory Affairs, Allucent

Rosenheim, Deutschland

Über mich

Regulatory Affairs Expert with >12 years' global experience (NDAs/BLAs, MAAs, CMAs, and NDSs) and a strategic, pragmatic mindset - from concept to market

Fähigkeiten und Kenntnisse

Regulatory Strategy
Drug Development
Leadership
Intercultural competence
Professional experience
Reliability
Creativity
International experience
Analytical skills
Empathy
Enthusiasm
Leadership skills
Communication skills
Presentation skills
Market Access / Health Technology Assessment

Werdegang

Berufserfahrung von Diana Radovan

  • Bis heute 2 Jahre und 7 Monate, seit Nov. 2021

    Director, Head of Regulatory Affairs

    Plusultra pharma GmbH

    Plusultra pharma GmbH (PUP) | Mission: Contribute to Society by Providing Critical but Neglected Pharmaceuticals and Medical Devices. PUP belongs to the Nobelpharma group of companies. Nobelpharma develops drugs, medical devices, and drug-device combinations. -Regulatory Strategy including HTA process (AMNOG and NICE) -Line, vendor & cross-functional management -Medical Affairs and PV activities -Due diligence for in-licensing -Inspection readiness -Developing SOPs & best practices.

  • 10 Monate, Jan. 2021 - Okt. 2021

    Associate Director Regulatory Affairs

    Allucent

  • 6 Monate, Juli 2020 - Dez. 2020

    Senior Consultant (Global Regulatory Affairs)

    Biopharma Excellence

    Drug Development | Regulatory Strategy | Agency Meetings | Due Diligence and Partnering | Training

  • 6 Monate, Jan. 2020 - Juni 2020

    Principal Medical Writer

    Trilogy Writing & Consulting GmbH
  • 1 Jahr und 7 Monate, Juni 2018 - Dez. 2019

    Senior Medical Writer

    Trilogy Writing & Consulting GmbH
  • 2 Jahre und 2 Monate, Apr. 2016 - Mai 2018

    Medical Writer

    Sandoz, a Novartis Division

    Writing of clinical study reports and submission documents for biosimilars in various indications

  • 4 Jahre und 6 Monate, Okt. 2011 - März 2016

    Medical Writer

    Boehringer Ingelheim Pharma GmbH und Co. KG

    Writer with experience in biomedical research, editing, and science communication and outreach Main skills: writing of regulatory documents (clinical study reports and submission documents), project management, international cross-disciplinary teamwork, providing training to external and internal medical writers, leading scientific and medical writing workshops Therapeutic areas: metabolism, respiratory, immunology

  • 1 Jahr und 8 Monate, Nov. 2009 - Juni 2011

    Postdoctoral Fellow

    University of Calgary

  • 2 Jahre und 11 Monate, Dez. 2006 - Okt. 2009

    Research Associate

    TU Dortmund

    Supervising practical courses, offering training to BSc and MSc students

Ausbildung von Diana Radovan

  • 3 Jahre und 2 Monate, Sep. 2006 - Okt. 2009

    Membrane Biophysics

    TU Dortmund

    Fluorescence microscopy studies on the fibrillation of IAPP at model and cellular lipid interfaces -- from mechanism to potential strategies in the treatment of type II diabetes mellitus

  • 1 Jahr und 10 Monate, Okt. 2004 - Juli 2006

    Biochemistry and Molecular Biology

    University of Bremen

    BSH-induced leakage of various liposomal formulations for future cancer therapy applications

  • 3 Jahre und 9 Monate, Okt. 2000 - Juni 2004

    Chemistry

    West University of Timisoara

    Biochemistry

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Fließend

  • Französisch

    Gut

  • Spanisch

    Gut

  • Rumänisch

    Muttersprache

Interessen

personal and professional development
mentoring
coaching
project- and people management
managing ideas
inspiring creativity
regulatory affairs
drug development
medical affairs
regulatory innovation
regulatory policy
patient advocacy

21 Mio. XING Mitglieder, von A bis Z