Regulatory Affairs Associate manager
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.
Lonza is establishing a strategic bio manufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market.
As Regulatory Affairs Associate Manager, you are responsible for the manufacture of therapeutic proteins under current Good Manufacturing Practice conditions. You will support CMC project activities for customers, working collaboratively with company personnel to co-ordinate the regulatory CMC activities for CTA and license applications. Provide regulatory support and advice for the Guangzhou site and support in site specific regulatory documents.
- Prepare and support clinical trial and product license applications for customers (for mammalian products). This includes the following:
- Write / review CMC sections;
- Prepare briefing documents for agency meetings;
- Attend customer meetings and project team meetings;
- Devise and maintain regulatory project plans in line with best practice recommendations;
- Update functional leads and maintain transparency of information across regulatory function.
- Provide regulatory support and advice to internal customers in line with defined Regulatory plans and in response to ad-hoc questions.
- Provide regulatory assessments and approvals for change controls and deviations.
- Support site specific regulatory documents.
- Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the LPB RA team.
- Perform other duties as assigned.
- Bachelor or above in biology/biochemistry major;
- Substantial experience in preparing and authoring CMC sections for early phase applications and license applications.
- Good proficiency in English and Mandarin;
- Good communication skills
- Ensures delivery excellence for his/her own goals
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.