Associate Director, CMC

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OtherAssociate

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Quick Summary

Key Responsibilities

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,

Requirements Summary

Collaborate with departmental and cross-functional partners to share technical and regulatory knowledge, align expectations, coordinate planning and monitoring activities, and mitigate risks.

Technical Tools

OtherAssociate

Job Description

Responsibilities

~2 min read

→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 industry associations and participate in CMC initiatives and task forces.

Requirements

→BS, MS or PhD degree in chemistry, biology, or related scientific disciplines; advanced degree is preferred;
→Expertise in CMC areas such as chemistry, formulation and analytical, at least 5 years of R&D and/or regulatory experience;
→Knowledge in CMC regulatory requirements and ICH guidelines;
→Good oral and written communication skills in both English and Chinese;
→Proven ability in cross-functional cooperation, alignment and ownership in problem solving;
→Experience in managing and coaching a high performing team.

CMC Development, CMC Strategy, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking, Team Management, Vendor Management