Associate Director, CMC

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From MSD’s original posting

Job Description Job Responsibilities • Leadership and Team Management: Manage a team within China RA CMC, including performance management, training, workload oversight, and support for a healthy work-life balance. Ensure team activities are delivered effectively, efficiently, and in compliance with external regulatory requirements and internal quality procedures. • Cross-functional Collaboration and Risk Management: Collaborate with departmental and cross-functional partners to share technical and regulatory knowledge, align expectations, coordinate planning and monitoring activities, and mitigate risks. • CMC Regulatory Submissions: Deliver timely and efficient CMC regulatory submissions across drug development and the lifecycle management. • Technical Regulatory Support: Partner with regulatory colleagues on product specifications, quality control testing, and inspection-related matters; provide technical input and facilitate discussions between China and HQ teams. • Project Team Engagement: Participate in China project development teams and work with regulatory and project leads to identify and address CMC needs. • External Engagement: Build networks with pharmaceutical…