Associate Director, CMC

About the role

The Associate Director, CMC will lead the China Regulatory Affairs CMC team, ensuring high‑quality regulatory submissions and compliance throughout the product lifecycle. This senior position partners with both local and global teams to drive CMC strategy and execution.

Key responsibilities

• Manage and develop a high‑performing CMC team, overseeing performance, training, workload, and work‑life balance.
• Coordinate cross‑functional collaboration, sharing technical and regulatory knowledge, aligning expectations, and mitigating risks.
• Prepare and deliver timely CMC regulatory submissions for drug development and lifecycle management.
• Provide technical regulatory support on product specifications, quality control testing, and inspection matters, acting as liaison between China and HQ.
• Engage in China project development teams to identify and address CMC requirements.
• Build networks with industry associations and contribute to CMC initiatives and task forces.

Required profile

• BS, MS or PhD in chemistry, biology or related scientific discipline; advanced degree preferred.
• Minimum 5 years of R&D and/or regulatory experience in CMC (chemistry, formulation, analytical).
• Strong knowledge of CMC regulatory requirements and ICH guidelines.
• Excellent oral and written communication skills in English and Chinese.
• Proven ability to cooperate cross‑functionally, solve problems, and lead a team.

Required skills

• CMC Development
• CMC Strategy
• Regulatory Submissions
• Chemistry
• Formulation
• Analytical