Expertise in building and implementing global regulatory strategies.
About
My Background
Proven capability and expertise in providing global IVD development, clinical and regulatory strategies to support Dx and Rx collaborations in oncology and pre-market submissions.
Excellent collaboration and communication skills in leading drug-diagnostic co-development interactions with major pharma companies globally.
Regulatory Affairs professional with a proven record in the development and pre-market authorization of companion diagnostics.
Extensive experience in regulatory submissions and communications with regulatory authorities (PMAs, 510(k)s, IDEs, Pre-submissions; FDA/PMDA/NMPA/MFDS/TGA/HC).
Broad-based knowledge encompassing IVD product development, design control, clinical trials, regulatory submissions, commercialization, risk management and product cycle management, to properly guide successful product launches and updates.
Business-oriented, with unique record in private, public, and academic enterprises.
Services
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