北京招聘

Job Summary:

Responsible for the Regulatory Affairs Activities of Teva Generic / new product portfolio of CNS/Anti-infection and Regulatory intelligence. Leading on regulatory Intelligence and assessment, project regulatory strategy setting and regulatory submission and maintenance activities, to ensure timely submissions / approval of responsible products and delivery of regulatory intelligence. The position requires in related RA knowledge, experience and understanding of China regulatory regulations.

Major Accountabilities:

• Develop China regulatory strategies, including regulatory risk assessments, and support for all development compounds (registration) and marketed products (life cycle management) in responsible TAs.
• Ensure the registration strategy flawless implemented for Gx and new drugs application sub, and approval, including local clinical trial permits applications, Int’l CTA, BE, import drug license applications.
• Prepare and compile regulatory dossiers for submission and ensure submission projects are on track and filed in a timely manner.
• Support China operations on relevant legislation, directives and regulations within China including OTC, Gx and Specialty business in responsible TAs
• Supervise, mentor subordinates
• Work closely with internal partners to ensure compliance with internal process and external regulatory requirements
• Establish & maintain good relationship with HA
• Establish & manage Regulatory Intelligence working process
• Monitor, anticipate, collect and interpret regulatory issues, regulation update and trends that will impact China products, policies and procedures, share this information with regulatory TAs, appropriate regional functions and assist in the development of strategies and plans of action to address them.

Qualifications & Requirements:

• At least University Degree in life science, medicine, pharmacy or material science.

• At least 6 years’ experience of regulatory affairs in the pharmaceutical industry.
• Good knowledge in registration and assessment of imported drugs and Gx.
• Good knowledge of regulatory and healthcare system in China.
• Strong English communication skills both written and oral in view of building effective stakeholder relationship.
• Excellent interpersonal skills , teamwork and collaboration.
• Understanding of local regulatory environment, key initiatives – specifically regulation change and trends.
• Innovative and creative, openness to change and ability to think out of box.
• Demonstrated project management ability.
• Results oriented, entrepreneurial and self-motivating

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。