Experience

PreciHealth

• Switzerland
• Medical Equipment Manufacturing
• 1 - 100 Employee

• QARA Manager

  • Sep 2023 - Present

  Lead registration in US and EU markets for medical devices that will positively impact the patient experience for a routine procedure. Lead registration in US and EU markets for medical devices that will positively impact the patient experience for a routine procedure.



SOPHiA GENETICS

• Switzerland
• Biotechnology Research
• 400 - 500 Employee

• Director of Regulatory Affairs

  • Mar 2022 - Jun 2023

  Compilation of Technical Files and development records for software-based in vitro diagnostic devices and clinical decision support software used to identify genomic variations related to various cancers. Compilation of Technical Files and development records for software-based in vitro diagnostic devices and clinical decision support software used to identify genomic variations related to various cancers.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Sr Manager, Digital

  • Apr 2020 - Feb 2022

• Regulatory Affairs Senior Manager, Digital Devices Pain Relief Category

  • Apr 2017 - Apr 2020

  Developing connected digital medical devices for a range of global markets.

• Regulatory Affairs Manager, Pain Relief Category

  • Jul 2015 - Mar 2017

  Development to registration medical products for an OTC population in a range of global markets



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Manager, Pain Category

  • Jul 2011 - Jul 2015

  Strategy planning for development products, Coordination and preparation for scientific advice meetings. Regulatory support for clinical trials. Response coordination and preparation for scientific advice meetings. Roll-out submissions for new products. Maintenance of business activities (renewals, PSURs, variations). Review of SOPs and working instructions. Participation in many cross functional workgroups. Mentoring new colleagues based both locally and globally.

• Regulatory Affairs Manager (Global Labelling )

  • May 2008 - Jun 2011

  - Create and manage core data sheets for company products- Organise team respose and create response document for all Health Authority deficiency letters, questions, requests for information- Provide regulatory input for PSURs- Contribute to SOP creation

• Regulatory Affairs Manager (Global Labelling)

  • Feb 2007 - Apr 2008

  - Create and manage core data sheets for company products- Organise team respose and create response document for all Health Authority deficiency letters, questions, requests for information- Provide regulatory input for PSURs- Contribute to SOP creation



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Manager (EU maintenance)

  • Aug 2006 - Dec 2006

  - Prepare documentation for variations (MRP or CP) - prepare documentation for renewals (MRP or CP) - manage PIL user tests - coordinate with Global Labelling for HA requests - create tool to track the resources of the group per activity and per product - Prepare documentation for variations (MRP or CP) - prepare documentation for renewals (MRP or CP) - manage PIL user tests - coordinate with Global Labelling for HA requests - create tool to track the resources of the group per activity and per product



University of Lausanne - UNIL

• Switzerland
• Research Services
• 700 & Above Employee

• Post-doctoral research associate

  • Feb 2003 - Jul 2006



University of Strasbourg

• France
• Higher Education
• 700 & Above Employee

• Postdoctoral Researcher

  • Nov 2001 - Nov 2002



Novartis Agribusiness (currently Syngenta)

• RTP North Carolina

• Scientist (summer)

  • May 1999 - Aug 1999