Regulatory Affairs(RA) Supervisor
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 Guangzhou Nansha Ltd was established in April 2003, expanding Lonza’s global presence for chemical manufacturing and life science ingredients.
Regulatory Affairs Supervisor will execute the Chinese and international drug registration according to the business needs, assist Nansha and other sites by providing local and regional regulatory consultation services and keep effective communication with Health Authorities and customers on regulatory affairs.
- To coordinate worldwide product registration activities for Nansha and its customers.
- To provide consultation services and regulatory solutions to assist quality management and manufacturing operation in Nansha.
- To maintain product licenses, establishment registration, DMF, PMF, etc for Nansha.
- Collect and analysis local and regional regulatory information, and conduct regulatory training to internal staffs.
- To establish/ maintain communication channels with health authorities.
- GMP Responsibility:
- To assess Change Requests for regulatory impact.
- To maintain SMF and site licenses, e.g. Drug Manufacturing License, Written Confirmation etc.
- Perform other duties as assigned.
- Bachelor degree or above majoring in Pharmacy and chemistry or relevant major.
- Significant experience in drug registration.
- Fluent in Chinese and English.
- Good communication with good rational & logics , and be careful, positive and responsible.
People come to 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.