RA Specialist

China, Nansha

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Regulatory Affairs Specialist is responsible for communicating with health authorities, for filing and maintaining product & establishment licenses, and for working with QA and other stakeholders to ensure in compliance with China and international regulatory requirements.

Key responsibilities:

  • Drug registration consulting;
  • Related license application and renewal;
  • Collect information about regulatory filling;
  • Prepare and submit registration dossier;
  • Follow up notices from authorities;
  • Provide regulatory supports to Nansha site operation;
  • Provide regulatory supports across Lonza sites.

Key requirements:

  • Bachelor degree, Pharmacy and chemistry or relevant major is prefer;
  • At least 1 year related working experience, preferable on drug registration;
  • Certification of Regulatory Affairs Specialist issued by GDFDA;
  • To be familiar with GMP and registration relevant guidelines & regulation;
  • Good command of English;
  • Good at communication;
  • Be patient and have a passion to work on documentation.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R32504