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
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
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
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