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 alignment across global teams.

•      Lead regulatory communications and meetings with authorities to support customer filings and Lonza’s strategic plans for ADS in China.

•      Oversee and improve high‑quality regulatory submission processes, including direct responsibility for clinical trial and license applications, and support for manufacturing licenses and DMFs.

•      Collaborate with local and global RA and functional teams to coordinate regulatory submissions across clinical development, commercialization, and post‑approval lifecycle management.

•      Support regulatory capability building, including developing regulatory talent, onboarding new hires, and contributing to global and local RA initiatives.

Qualifications

•      Degree ：Life Sciences graduate, educated to degree level.

•      Field of Study: Chemistry, biochemistry or equivalent education and at least 10 years of experience in industry.（biology, chemistry, biochemistry, pharmacy)

•      Expertise in the interpretation and communication of regulatory requirements in China

•      Expertise in the interpretation of CMC requirements

•      Established contacts and communications with Health Authorities in China

•      Good understanding of biologicals, specifically mammalian fermentation

•      Experience in participating in Domestic and International Regulatory interactions is required.

•      Demonstrated skills managing project timelines and leading preparation of CMC sections in projects.

•      Excellent organizational stills and attention to details

•      Excellent communication and interpersonal skills

•      Ability to review and critique complex technical documents

•      Strategic approach and system oriented toward goals and objectives

•      Ability to represent the company on regulatory issues both internally and externally

•      Strong interpersonal skills and ability to interact positively with all functions and levels

•      Excellent team leader and team member