Nina Unterwaditzer
Kramsach
Summary
A results-driven and dedicated professional with exceptional leadership skills and a passion for driving organizational success. Seeking a challenging global leadership role in Global Regulatory Affairs where I can leverage my diverse experience, strategic mindset, and strong dedication to lead high-performing teams and achieve business objectives. Committed to fostering innovation, driving operational excellence, and delivering impactful solutions that positively impact patient outcomes and business growth.
Overview
19
19
years of professional experience
Work History
Head Regulatory Affairs Growth and Mature Brands
Sandoz Biopharmaceuticals
2021.03 - Current
- Resolved problems, improved operations and provided exceptional service.
- Worked well in a team setting, providing support and guidance.
- Proven ability to develop and implement creative solutions to complex problems.
Head Regulatory Labeling & Lifecycle Management
Sandoz Biopharmaceuticals
2019.04 - 2021.03
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Proved successful working within tight deadlines and a fast-paced environment.
Head Regulatory Labeling
Sandoz Biopharmaceuticals
2017.03 - 2019.03
- Exercised leadership capabilities by successfully motivating and inspiring others.
- Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
- Demonstrated leadership skills in managing projects from concept to completion.
Regulatory Labeling Manager
Sandoz Biopharmaceuticals
2013.06 - 2017.02
- Increasing responsibility; - Team Leader Labelling Group (a.i.) (01-02 / 2017) - Leader Pharmacovigilance functional working team - Regulatory Labelling Manager
GMP-Compliance Manager
Sandoz, Quality Assurance Pharma Operations
2011.06 - 2012.05
Clinical Safety (Quality) Manager
Sandoz, Global Quality Assurance
2007.10 - 2010.05
- Increasing responsibility: - Clinical Safety Quality Manager - Clinical Safety Manager
Postdoctoral Researcher
University Of Texas At Austin
2006.08 - 2007.04
- Collaborated with researchers and scientists to design and execute experiments.
- Leveraged interpersonal and communication skills to mentor PhD, graduate and undergraduate students.
- Presented research findings at international conferences, fostering knowledge exchange among peers.
- Assisted scientists by collecting and organizing laboratory data.
Postdoctoral Researcher
Harvard University, Cambridge
2005.09 - 2006.08
- Collaborated with researchers and scientists to design and execute experiments.
- Leveraged interpersonal and communication skills to mentor PhD, graduate and undergraduate students.
- Presented research findings at international conferences, fostering knowledge exchange among peers.
- Conducted research in area of functional genomics
Education
PhD in Biology -
Karl-Franzens University Graz
Austria04.2005
Masters degree in Biology -
Leopold-Franzens University Innsbruck
Austria07.2001
Skills
organizational development
stakeholder management
team management
strategic planning
Languages
German
Native language
German
Beginner
A1
English (fluent)
Beginner
A1
Spanish (basics)
Beginner
A1
Scholarships And Awards
- 2005 Dr. Maria Schaumayer Prize; Dr. Maria Schaumayer Stiftung, Austria
- 2004 PhD scholarship DOC-FFORTE; Austrian Academy of Sciences
- Research grant for graduate students; University of Innsbruck
- 2001 Stipend for special study achievement (Leistungsstipendium); University of Innsbruck
- Various scholarships for attending international conferences, scientific courses and research expeditions
- 2003 - 2006 Erwin-Schrödinger-Postdoctoral Fellowship; FWF Austria
Personal Interests Activities
- Cycling (in the past at a competitive level)
- Cross-country skiing
- Hiking
- Sports
- Travelling
- Youth work
- Other Painting
- Reading
Training
- Management Leading Teams, Kitzbuehel
- Pharmacovigilance IMS Pharmacovigilance Workshop, Basel
- Presentation Skills, Kundl
- Pharmacovigilance 2009, Vienna
- Successful Meetings, Bad Haering
- Clinical Trials according to AMG & ICH GCP, Mannheim
- Regulatory Affairs ExpertFORUM Labelling, Frankfurt
Timeline
Head Regulatory Affairs Growth and Mature Brands
Sandoz Biopharmaceuticals
2021.03 - Current
Head Regulatory Labeling & Lifecycle Management
Sandoz Biopharmaceuticals
2019.04 - 2021.03
Head Regulatory Labeling
Sandoz Biopharmaceuticals
2017.03 - 2019.03
Regulatory Labeling Manager
Sandoz Biopharmaceuticals
2013.06 - 2017.02
GMP-Compliance Manager
Sandoz, Quality Assurance Pharma Operations
2011.06 - 2012.05
Clinical Safety (Quality) Manager
Sandoz, Global Quality Assurance
2007.10 - 2010.05
Postdoctoral Researcher
University Of Texas At Austin
2006.08 - 2007.04
Postdoctoral Researcher
Harvard University, Cambridge
2005.09 - 2006.08
PhD in Biology -
Karl-Franzens University Graz
Masters degree in Biology -
Leopold-Franzens University Innsbruck
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