Leads and oversees the development and implementation of regulatory CMC development and registration strategies for the Biologics CMC team. China RA CMC member on Global Regulatory CMC, Global Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial life cycle for assigned products and staff.
Demonstrates high level of leadership and expert understanding of CMC and quality regulations and guidelines and expert up-to-date CMC knowledge and skill to address and overcome challenges that arise during development and commercialization.
Manages and/or mentors staff members.
Development constructive relationships with proactively communicates issues to key internal and external stakeholders.
Provides regulatory CMC expertise for new business development/due diligence activities.
Combines knowledge of scientific, regulatory and business issues to ensure the re...
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