PRIMARY FUNCTION. Maintain the effectiveness of global clinical/GLP quality management system, including monitor US/EU/Japan clinical regulation updates and communicate the changes to global pre-clinical and clinical quality team. Contribute to Quality and Risk Management Framework across clinical and non-clinical R&D team. Lead quality issue investigation and CAPA approval. Drive continuous improvement in clinical trials quality. Lead internatio...
PRIMARY FUNCTION. The mission of HUTCHMED International Regulatory Affairs is to develop innovative global registration strategies that advance our pipeline through approval in US, EU, and other countries. In this position, the Regulatory Affairs CMC Director/Senior Director/Executive Director will lead the international Regulatory Affairs CMC team and support the development of sound global CMC regulatory registration strategies to support HUTCH...
Responsibilities：. This position is an opportunity for someone interested in working for a fast paced and global science-focused biopharma. The Exc. Director - SVP will get involved in all activities related to BD&L, including opportunity assessments, prioritization, due diligence, financial modeling, valuation, and contract negotiations. This person will be an integral member of the Business Development team and will collaborate extensively with...
