Regulatory Affairs Manager
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 Manager 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.
- Lead product registration activities in Great China Region for Lonza and its customers.
- Coordinate worldwide product registration activities for Lonza Nansha and its customers.
- Provide consultation services and regulatory solutions to assist quality management, manufacturing operation and business needs in Lonza Nansha.
- Maintain product licenses, establishment registration, DMF, PMF, etc for Lonza Nansha.
- Promote regulatory knowledge and trends by sharing RIB in Quality Council, distribution of Newsletter, conducing training, etc.
- 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.
- Manage Lonza Nansha RA department.
- Perform other duties as assigned.
- Bachelor degree or above majoring in Pharmacy and chemistry or relevant major.
- Extensive experience in drug registration & regulatory affairs management.
- Fluent in Chinese and English.
- Certification of Regulatory Affairs Specialist is preferred
- Good communication with good rational & logics , and be careful, positive and responsible.
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.