岗位职责：

This position is responsible for facilitating CMC activities for the small molecule projects in China. This individual will report to the Head of CMC Management and serve as the CMC manager of the small molecule projects. Roles include, but are not limited to, overseeing the China CMC sub-team in tracking project status, assessing project issues, and developing resolutions to achieve goals of IND/NDA filing and stakeholder satisfactions.

1.CMC management

Develop a clear CMC strategy and communicate well with the global CMC Team members, from an overall optimization perspective with in-depth CMC knowledge. Consider Plan B development from a risk management perspective. Be proactive in resolving issues and challenges encountered during the assignment. Responsible for the overall status of the project with respect to budget, timeline, and achievement of defined milestones.

2. Regulatory Affairs

Actively manage CMC aspects of regulatory submissions (IND, NDA, etc.) and interactions with health authority. Work with RACMC to schedule regulatory affairs-related CMC tasks for clinical trial application. Collaborate with RACMC to coordinate the content and timing of consultation to authority.

3. Cross-functional communications

Ensure effective communication and collaboration between all relevant functions and third parties., Participate in project teams as a representative for CMC related tasks, accurately assess project status and provide appropriate solutions to any issues through close communication with global CMC management and local China project members. Establish a culture of open communication and effective collaboration, driving consensus but willing to take a stand when necessary.

应聘要求：

•Master or PhD degree in Life Sciences, Chemistry, Pharmacy, or related field.

•Minimum 5 years of experience in the small molecule area of the pharmaceutical industry.

•Extensive knowledge of all aspects of chemical-pharmaceutical CMC is preferred.

•Experience with process development, manufacturing, IND and NDA filings and familiarity with relevant NMPA, FDA, and EMA regulations.

•Experience in interacting with NIFDC is preferred.

•Fluent in written and verbal English.

•Strong project management and time management skills.

•Excellent interpersonal and communication skills with the ability to build strong rapport with all levels of the organization.

•Experience in communicating with international teams is a plus.

•Familiar with Microsoft Office