泰合生技藥品股份有限公司

• Responsible for regulatory plans, submission, and approval of clinical trial and marketing authorization applications i.e. compiling and reviewing IND and ANDA documents to ensure compliance with international and regional regulatory standards. • Ensures all documents submitted to regulatory agencies are complete, well organized, in regulatory compliance, and presented in manner that facilitates agency review. • Responsible for maintaining records of regulatory submissions and communications with the relevant regulatory agencies. • Coordinate with internal teams to ensure product compliance and registration progress. • Provide technical and regulatory expertise, assisting in resolving product development an • Manager projects with third party vendors and contractors to meet schedules and ensure quality. • Perform other duties as assigned.

• Work hands-on in the laboratory to develop, optimize, qualify, transfer, and validate analytical test methods for both drug substance and drug product, from preclinical nomination through late-phase clinical development; • Conduct in-house stability studies and interpret stability data to justify material use periods; • Build kinetic stability models for formulation screening and packaging selection; • Author high-quality documentation, including methods, protocols, and technical reports; • Coordinate and oversee method validation and testing at contract laboratories and manufacturers; • Collaborate with others scientists on CMC teams to meet program goals; • Act as an exemplary and data-driven scientist with critical thinking and innovative problem solving skills in a fast‑paced, can-do environment.

• Providing technical expertise/scientific input on formulation development strategies • Preparation and practical execution of formulation development projects • Providing scientific expertise and formulation insights to Core Teams meetings • Review test results in alignment with the project goals, identify causes of variances and recommend solutions to achieve goals. • Supporting the scale-up of developed formulations and bringing them to GMP manufacturing • Schedule experiments and prioritize assignments to meet project objectives and deadline. • Maintain laboratory equipment and chemicals in a safe manner. • Responsible for writing up R&D documents and research reports.