Experience

Believer Meats

• Israel
• Food and Beverage Services
• 1 - 100 Employee

• Regulatory Affairs Project Manager

  • Nov 2021 - Present



SciVac Limited

• Israel
• Biotechnology
• 1 - 100 Employee

• RA Specialist

  • 2019 - Dec 2021

  Support of BLA and MAA Submission (CMCs sections). Provide RA review of change control assessments Review and approve change documentation, while considering US, EU and other international regulatory requirements. Provide manufacturing site RA support. Ensure validity and accuracy of data. Lead /participate in cross functional project teams. Support of BLA and MAA Submission (CMCs sections). Provide RA review of change control assessments Review and approve change documentation, while considering US, EU and other international regulatory requirements. Provide manufacturing site RA support. Ensure validity and accuracy of data. Lead /participate in cross functional project teams.



Perrigo Company plc

• Ireland
• Manufacturing
• 700 & Above Employee

• Regulatory affairs

  • 2013 - 2019

  Provided CMC regulatory guidance for submissions and CMC changes, such as analytical, specification and manufacturing changes for US Market. Provided manufacturing site RA support. Provided RA review of document changes. Supported supplements and annual reports submissions for all active drugs (NDAs and ANDAs). Participated in meetings with other functional groups on CMC regulatory issues. Contributed to development and implementation of new and improved processes. Provided CMC regulatory guidance for submissions and CMC changes, such as analytical, specification and manufacturing changes for US Market. Provided manufacturing site RA support. Provided RA review of document changes. Supported supplements and annual reports submissions for all active drugs (NDAs and ANDAs). Participated in meetings with other functional groups on CMC regulatory issues. Contributed to development and implementation of new and improved processes.



Soroka Medical Center

• Israel
• Hospitals and Health Care
• 200 - 300 Employee

• Study coordinator in Diabetic clinic-

  • 2012 - 2013

  Worked together with CROs and Pharmaceutical companies and supported site audits. Patient recruitment, visits management according to protocol. Worked in compliance to Helsinki committee guidelines. Worked together with CROs and Pharmaceutical companies and supported site audits. Patient recruitment, visits management according to protocol. Worked in compliance to Helsinki committee guidelines.