Associate Director, Regulatory Affairs

<p style="text-align:inherit">&nbsp;</p><p style="text-align:inherit"></p><p>•      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.</p><p>•      Establish and maintain strong communications with Chinese Health Authorities, acting as the primary regulatory interface for Lonza ADS.</p><p>•      Provide expert regulatory guidance to the Nansha site and cross‑functional teams to support product development, tech transfers, manufacturing changes, and lifecycle management.</p><p>•      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.</p><p>•      Support Lonza customers entering or expanding into the China market, providing clear pathways and regulatory expectations.</p><p>•      Interpret and communicate China‑specific regulatory requirements applicable to ADS‑manufactured products and ensure regulatory alignment across global teams.</p><p>•      Lead regulatory communications and meetings with authorities to support customer filings and Lonza’s strategic plans for ADS in China.</p><p>•      Oversee and improve high‑quality regulatory submission processes, including direct responsibility for clinical trial and license applications, and support for manufacturing licenses and DMFs.</p><p>•      Collaborate with local and global RA and functional teams to coordinate regulatory submissions across clinical development, commercialization, and post‑approval lifecycle management.</p><p>•      Support regulatory capability building, including developing regulatory talent, onboarding new hires, and contributing to global and local RA initiatives.</p><p></p><p><b>Qualifications</b></p><p>•      Degree &#xff1a;Life Sciences graduate, educated to degree level.</p><p>•      Field of Study: Chemistry, biochemistry or equivalent education and at least 10 years of experience in industry.&#xff08;biology, chemistry, biochemistry, pharmacy)</p><p>•      Expertise in the interpretation and communication of regulatory requirements in China</p><p>•      Expertise in the interpretation of CMC requirements</p><p>•      Established contacts and communications with Health Authorities in China</p><p>•      Good understanding of biologicals, specifically mammalian fermentation</p><p>•      Experience in participating in Domestic and International Regulatory interactions is required.</p><p>•      Demonstrated skills managing project timelines and leading preparation of CMC sections in projects.</p><p>•      Excellent organizational stills and attention to details</p><p>•      Excellent communication and interpersonal skills</p><p>•      Ability to review and critique complex technical documents</p><p>•      Strategic approach and system oriented toward goals and objectives</p><p>•      Ability to represent the company on regulatory issues both internally and externally</p><p>•      Strong interpersonal skills and ability to interact positively with all functions and levels</p><p>•      Excellent team leader and team member</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>