会社概要
Leader of AI-driven Liquid Biopsy technology for treatment selection, recurrance and early detection of cancer.
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仕事内容
Create and lead regulatory strategy for Japan market, including both medical devices and biomarker pipeline
Communicate closely with global HQ in the US to gather all information needed to build a logical story to convince the PMDA to approve the product in japan
Liaise strategically with government and industry bodies to lobby for policy reform for liquid biopsy in Japan
Manage and direct a team of regulatory specialists in Japan to meet deadlines for submission and develop their capability as leaders in the company
応募資格
Minimum 8 years of Regulatory Affairs experience
IVD, or drug/device combination product preferred
Track record of leadership to obtain approval of new category products