Associate Director, Regulatory Affairs

• Lead the development and execution of regulatory strategies for China, ensuring compliance with NMPA and Local HA regulations and alignment with ADS and global RA objectives.

• Establish and maintain strong communications with Chinese Health Authorities, acting as the primary regulatory interface for Lonza ADS.

• Provide expert regulatory guidance to the Nansha site and cross‑functional teams to support product development, tech transfers, manufacturing changes, and lifecycle management.

• Identify regulatory risks and opportunities, offering clear recommendations and mitigation strategies for China-specific as well as for programs the manufacturing site requires Regulatory Affairs support for.

• Support Lonza customers entering or expanding into the China market, providing clear pathways and regulatory expectations.

• Interpret and communicate China‑specific regulatory requirements applicable to ADS‑manufactured products and ensure regulatory alignme...

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