上海招聘

Responsibility:
1. In the broad sense, Regulatory Affairs means activities by which evidence is established to prove product safety in accordance with legal (regulated) standards so that consumers and users are assured protection against detriments to their health.
2. Prepare regulatory submissions and act as a liaison with the SFDA and manufacturer to facilitate timely approvals of product registration, for both import and locally manufactured products.
3. Manages, provides leadership, interacts, and coordinates multifunctional teams including outside consultants, clinical research organizations, and other professional bodies to prepare and submit product registration dossiers and other regulatory reports and applications to nationwide regulatory agencies. In this context, form strong professional relationships with key-influential political, regulatory and trade association contacts.
4. Coordinates clinical trials and BE studies as required by SFDA and other regulatory bodies, establishing monitoring systems, involving in protocol design and negotiations.
5. Maintain up to date knowledge on all regulatory issues so as to understand its implication on assigned projects. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays. Provides strategies to pre-empt, troubleshoots, and resolves problems.
6. Understand and accommodate the needs of the Marketing department in terms of packaging and product label requirements, advertising material etc. and liaise with the respective bodies for approval.
7. Maintains up to date filing systems of all regulatory documents and correspondences. Establish various information systems that allows quick assess to potential products for distribution rights or local manufacturing. Keep company management up to date on status of specific product registration actions, problems and solutions. Coordinates the scheduling and preparation of regulatory submissions in accordance with company goals and provides input for planning and status reports.
8. Set up and ensure company-wide compliance to policies, practices and procedures and overall R&D Records Management Policies
9. Support business operation on regulatory related issues

Qualification Requirements:
1. Degree in chemical pharmaceutical sciences preferred
2. Language: English and Mandarin (Good English written and oral communication skills, including grammar, spelling and punctuation)

欧瑞莲于1967年由翰林兄弟在瑞典创立，目前已成为市场遍布全球60多个国家的国际性美容品直销公司。

欧瑞莲拥有种类丰富的创新产品线，其“瑞典的、天然的、美容品”通过300多万独立销售顾问销往全球，造就每年逾13亿欧元的销售额。

欧瑞莲提供领先业界的事业机会，帮助人们从加入的***天起就赚取收入，同时朝着实现个人梦想和雄心的目标迈进，这就是我们独一无二的事业概念--“今天创造财富，明天成就梦想”。对于人与大自然的尊重，成为公司营运理念的基础，并体现在公司的社会和环境政策中。欧瑞莲世界儿童基金会的联合创始人，并为全球众多的慈善事业项目提供捐助。欧瑞莲是一家上市公司，股票在纳斯达克OMX北欧交易所上市。