Summary
Overview
Work History
Education
Skills
Languages
Scholarships And Awards
Personal Interests Activities
Training
Timeline
Generic
Nina Unterwaditzer

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
Austria
04.2005

Masters degree in Biology -

Leopold-Franzens University Innsbruck
Austria
07.2001

Skills

    organizational development

    stakeholder management

    team management

    strategic planning

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
Nina Unterwaditzer