广东省数字贸易与服务公共服务平台

The Head of Regulatory Affairs has overall responsibility over the Regulatory function of the Guangzhou site reporting to the Head of Regulatory Affairs for CDM Business Unit.

  The Head of Regulatory Affairs will support Regulatory Affairs CMC (biologics) project activities, work collaboratively with appropriate Lonza personnel and Customers to co-ordinate the regulatory stages of work, preparation of license and clinical trial applications, support meetings with Health Authorities and development of regulatory strategies for these products

• Direct responsibility for the preparation of clinical trial applications for customers

• Direct responsibility for the preparation of license applications for customers

• Maintain project plans for Regulatory

• Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to questions

• Support the Guangzhou site on Regulatory activities and queries from Health Authorities

• Support the Guangzhou site with interactions with Health Authorities

• Work collaboratively with appropriate company personnel to co-ordinate the regulatory work stream elements for products in clinical development. This will include:

  • Preparation and review of scientific and technical information

  • Regulatory strategy for mammalian products and communication on such matters with regulatory authorities

  • Scientific advice meetings and regulatory strategy

• Internal regulatory support:

  • Interpretation of applicable regulatory requirements for China

  • Act as regulatory contact in communication with regulatory agencies

  • Foster good relationships with Guangzhou FDA and NMPA

  • Support site in the review and approval of GMP document (Change controls and deviations)

  • Provide regulatory support and advice to Guangzhou site

                                Any other tasks as and when assigned by the superior

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

Do you want to help us as we shape the future of this great organization?

龙沙（中国）投资有限公司成立于2003年9月，是瑞士龙沙集团全资在广州设立的投资性公司。公司旨在于医药、化工及生命科学领域进行投资和再投资，同时提供以下服务：

-协助或代理龙沙所投资企业的货物及设备采购业务，并在国内外市场销售他们的产品；

-为龙沙所投资企业提供售后服务、技术支持及人力资源服务；

-为投资者提供咨询服务并为龙沙的关联公司提供市场信息、投资政策等咨询服务。