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.

• 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

Lonza