Regulatory Affairs
龙沙(中国)投资有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2021-01-11
- 工作地点:广州-南沙区
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:8-10万/年
- 职位类别:药品注册
职位描述
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 Professional will support Nutrition business in China and also support to global RA to carry out registration for nutrition products, and related duties about product safety.
Key responsibilities:
Carry out the registration for Nutrition products in China.
Provide regulatory support to customers (e.g. statement, FSC).
Review and evaluate the regulatory impact on the changes of manufacturing process of Nutrition products in China.
Provide product safety supports to business.
Track new regulations and evaluate the regulatory impact on business.
Build up and maintain good relation with authorities, association and third parties.
GMP Responsibility: evaluate and approve change requests, as well as RA related GMP training.
Perform other duties as assigned.
Key requirements:
Bachelor degree majoring in Pharmacy, Food Science, Biologic or related Sciences.
Significant experience in Regulatory management in Pharma, Food/ Healthcare related business.
Extensive knowledge in Pharma, Food / Healthcare industry.
Fluent in Chinese and English.
Team work spirit with good organizing, planning & communication skills.
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.
职能类别:药品注册
公司介绍
在龙沙,我们将技术创新与卓越生产及工艺完美结合,助力我们的客户在保健、防腐与保护领域实现他们的研发成果。
我们是全球制药、生物技术与特殊成分市场的优秀合作伙伴。 我们致力于疾病预防,并通过助力客户推出创新药物用以辅助治疗或治愈一系列的疾病,促进我们的世界更健康。同时,我们也提供广泛的微生物控制解决方案,共同营造和维护健康的环境。
1897年,龙沙诞生于瑞士的阿尔卑斯山脉地区,迄今拥有 120 个生产基地和办事处,遍布全球超过35个国家。 我们拥有约15,500名全职员工,由他们组成的高效团队及每一名员工都为我们的业务和所在地区及国家做出意义非凡的改变。2019 年,公司销售额达59亿瑞士法郎,核心业务的息税折旧摊销前利润(EBITDA)达16亿瑞士法郎。更多详情,请访问 *************。
About Lonza
At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.
We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.
Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at ************* and follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.
联系方式
- Email:Helen.xiang@lonza.com
- 公司地址:上海市黄浦区湖滨路150号企业天地5号楼2505-2506室