关键职责：

管理药品从研发到商业化全生命周期中的法规事务，包括临床试验申请（IND）、新药申请（NDA）等申报资料的撰写与提交、与监管机构的沟通协调、技术转移及工艺验证的法规合规性评估，以及应对监管审查，确保生产活动符合质量体系要求，从而保障产品在各阶段的合规上市。‌
希望候选人有大分子注册背景及海外临床注册经验，英文流利

Job Responsibility
·As the CMC leader of assigned projects for the company, provide technical leadership to steer the CMC activities en route to successful IND filing and/or late stage development and BLA submission to regulatory agencies such as US FDA, EMA, NMPA, WHO, etc.
·Participate and show leadership in establishing WuXi CMC strategies and recommendations to support all ongoing projects in CMC development.
·Lead CMC projects with good understanding of potential technical challenges and meeting the regulatory requirements and ICH guidelines.
·Collaborate with CMC functional areas to ensure successful execution of various CMC strategies, on-time delivery of results and staying within budget.
·Chart the course, track progress against goals and outline key strategic events for project. Manage project scope definitions and changes, and budgets.
·Serve as the center of solution for technical issues. Address any challenges and issues that arise. Make hard decisions if needed.
·Engage effectively with key stakeholders to ensure transparency on program status and alignment on program plans, goals, resource requirements and timelines.
· Build a solid communication with client to ensure alignment between WuXi and clients.
· Provide leadership in development and manufacturing alliance management, product development and manufacturing strategy
· Support BD efforts and proposal writing team to enhance current service offering and develop new clients.
Opportunities
· Broaden and deepen understanding and experience in development
· Gain cross-functional knowledge in real life

development and CMC management
· Develop leadership skill
· Enhance personal well-roundedness in preparation for executive capacity
Required Qualifications
· Advanced degree (PhD or MS) in Bio/Chemistry, Bio/Chemical Engineering, Life Sciences or related major with 10-15 years of applicable work experience. Exceptional candidates with 5-10 years of relevant working experience will also be considered.
·Proven track record of expertise in any areas of b CMC development (e.g., CLD, bioprocess, analytical, formulation, manufacturing science, etc.), good understanding of overall CMC strategy, risk and resource management, regulatory requirements and ICH guidelines.
· Demonstrated strategic decision-making abilities as well as problem-solving skills.
· Excellent verbal and written communication skills in both English and Chinese.
· Ability to work effectively across functions, teams and stakeholders.
· Excited at the vision and mission of WuXi and embracing WuXi

PROUD culture
Preferred Qualifications (Not Required)
· Previous working experience at or with CDMO a plus.
· Basic level in Korean, Japanese, Cantonese or other languages will be a plus.
· Experience in writing regulatory documents and submissions a plus