About me
Programmed to change the trajectory of patient lives by harnessing 10 years of strategic regulatory design and execution in oncology, rare diseases both BLA (cell & gene therapy) and NDA (oncology & neurological disorders) with successful Health Authority track record in complex innovative study design. Other accomplishments include a successful track record in regulatory partnership in licensing, mergers, and acquisitions across a wide variety of therapeutic areas. Experience includes deep knowledge in all eCTD modules (opened multiple INDs and averted Clinical Hold in all situations); and regulatory leadership in digital assets including mobile app
