Experience

Adrenomed AG

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Head of Regulatory Affairs

  • 2019년 6월 - – 현재

  Regulatory Affairs for clinical studies and Marketing Authorization Applications in EU and USA for new innovative antibody-based therapy. Regulatory Affairs for clinical studies and Marketing Authorization Applications in EU and USA for new innovative antibody-based therapy.



Inceptua Group

• Luxembourg
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Head of Quality and Regulatory Affairs

  • 2017년 11월 - 2019년 4월

  Head of Quality and Regulatory Affairs Department. Responsible for the development and maintenance of the Quality Management System (QMS) of Inceptua Group, with offices in EU, USA, JP and CN. Also responsible for the regulatory compliance of Inceptua Group with its activities in clinical trial supply, management of expanded access/compassionate use programms and supply of unlicenses medicines as well as during supply of its commercial products. Head of Quality and Regulatory Affairs Department. Responsible for the development and maintenance of the Quality Management System (QMS) of Inceptua Group, with offices in EU, USA, JP and CN. Also responsible for the regulatory compliance of Inceptua Group with its activities in clinical trial supply, management of expanded access/compassionate use programms and supply of unlicenses medicines as well as during supply of its commercial products.



Merz Therapeutics

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director Regulatory Affairs/Head Regulatory Affairs Prescription Medicines

  • 2015년 2월 - 2017년 9월

  Responsible for all Corporate regulatory aspects of new drug development and clinical trials globally.

• Director Regulatory Affairs/Head Clinical Trial Applications Group and Life Cycle Management Group

  • 2012년 7월 - 2015년 2월

  Responsible for all Clinical Trial Applications (Phase I-IV) and for regulatory Life Cycle Management of Merz global mature product portfolio (prescription drugs, OTC, devices, cosmetics) worldwide.

• Section Head Clinical Trial Applications

  • 2010년 7월 - 2012년 6월

  Head of Clinical Trial Applications Group within the Global Regulatory Affairs Department. Responsible for all regulatory aspects related to Merz Pharmaceuticals' clinical studies (phase I-IV) world wide.



i3 Research

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Associate Director Regulatory Affairs

  • 2007년 12월 - 2010년 7월

• Manager Regulatory Affairs

  • 2005년 12월 - 2007년 12월



SKM Oncology Research GmbH

• Manager Regulatory Affairs

  • 2004년 11월 - 2005년 12월



National Institute of Health (NIH)

• Post Doctoral Research Fellow

  • 2003년 1월 - 2004년 11월

  Post Doc in the Laboratory of Persistent Viral Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), led by Dr. B. Chesebro and Dr. K. Hasenkrug. Worked on the development of a gene-therapy HIV-vaccine based on a Lentiviral vector system. Post Doc in the Laboratory of Persistent Viral Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), led by Dr. B. Chesebro and Dr. K. Hasenkrug. Worked on the development of a gene-therapy HIV-vaccine based on a Lentiviral vector system.