北京招聘

Primary purpose and function of this position:
To lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirements, specifically China market.
Duties and Responsibilities:

• Support the life cycle management of APIs from RA perspective
• Review and approve ROS, specification and analytical control when required
• Coordinate DMF preparation and related activities for On Time Submissions for China market
• Proactively collaborates with the Regulatory Associates responsible for products (on site or new products), working as one team
• Respond to deficiency letters and coordinate related activities
• Coordinating pre-launch activities from RA perspective
• Manages the regulatory aspects and related tasks of the assigned commercial APIs
• o Evaluate change requests and address the required submission to support the requested change. Follow through the submission
• Maintain up to date the DMFs according to the required regulation of updating for China market.
• Support customers regarding Service Requests, giving relevant professional information in the shortest of time
• Continue learning of regulatory guidance, SOPs and work processes
• Additional responsibilities as part of Global community of TEVA api RA:
• Share knowledge on China regulatory within RA community
• Proactively suggest and support development/improvement of RA work processes in order to achieve constant improvement of our department
• To train new RA associates
• knowledge and experience to prepare a response to authorities DL requests without need of further assistance and guidance
• Leading local/global projects

任职要求：

• Education:
• High degree in relevant field, e.g. chemistry/biochemistry/biology or biotechnology
• Professional Experience:
• Experience of at least 3 years in Regulatory Affairs.
• Knowledgeable in China regulatory guidelines and NMPA requirements

Teva 是一家总部位于以色列的全球性医药公司，是全世界***的“药柜”，拥有超过1,800个分子化合物，35,000个产品。我们的使命是成为全球仿制药和生物制药的领导者，提高和改善病患的生活质量。目前Teva在全球共有43,000名员工，在近60个国家开展业务，2018年全年销售额接近190亿美金。现在Teva已经来到中国，作为全球使命的一部分，Teva 中国将会在未来的几年里大力拓展本土业务， 上市我们创新研发的原研药品，以高品质药品为中国数百万患者提供帮助。在未来，Teva承诺会为中国的病患，以更快的速度带来更新更好的药物。