上海招聘

在法规事务方面为产品管线的开发提供策略；

    

Provide strategies to the pipeline development in terms of Regulatory Affairs;

    

管理，审核注册文件；

    

Manage and review the content of regulatory dossiers;

监管并负责法规沟通交流，资料递交，后续跟进各药监机构的审评进展，以质量为中心确保***轮申报批准；

Oversee and be responsible for regulatory communication, submissions, and follow-up with further review progress in agencies, with a quality focus to secure first-cycle/attempt approvals;

    

代表公司参加重要的法规相关的会议，协调主持讨论；

    

Represent the company at key regulatory-related meetings; to moderate and lead discussions;

    

与法规专家和监管专家发展和保持有效的关系；

    

Develop and maintain effective relationships with regulatory officials, regulatory experts;

与药学，临床以及其他合同外包服务公司进行有效的沟通合作；

Effectively collaborate with cross-functional teams such as CMC, Clinical, CRO companies etc;

    

在了解现有监管程序、变更和趋势同时，积极预测和降低法规风险；

Proactively anticipate and mitigate regulatory risks while maintaining current knowledge of regulatory procedures, changes and trends;

    

提供申报差距分析，识别潜在的风险，并提出解决方案，以确保成功受理；

    

Provide submission gap analyses, identify potential risks and propose potential solution plans to ensure successful acceptance of submissions;

    

领导和发展一个专业的RA团队。

    

Lead and develop a team of RA professionals.

岗位任职要求

    

Knowledge, Experience, Skills and Abilities Required

    

硕士及以上学历，专业生命科学，药学，生物化学及其他相关专业;

    

Master degree or above in life science, Pharmacy, Biochemistry, other related majors;

    

8年以上从事NMPA/FDA/ EMA临床和上市产品递交的工作经验，至少12年工业界经验;

    

Minimum of 8+ years of direct regulatory affairs experience in the IND/BLA submission to NMPA/FDA/EMA and 12 years of industry experience;

    

5年以上的管理经验；

    

5+years of management experience;

    

有大分子，抗体类药物申报经验，有递交NMPA/FDA/EMA/ IND和NDA经验； 

Experience with global agencies such as NMPA/FDA/EMA in IND/NDA submissions for macromolecules, Antibodies;

    

出色的人际交往能力，在多个职能部门和组织之间建立牢固的关系；

    

Excellent interpersonal skills with the ability to build strong relationships across multiple functions and organizations;

    

优秀的中英文口头、书面和会议表达能力。

Excellent verbal, written communication and meeting presentation skills in both Chinese & English.

    

长春安沃高新生物制药有限公司成立于2019年3月,注册资本为2亿美元，坐落在长春市高新北区北湖开发区，是由长春高新技术产业（集团）股份有限公司与冰岛Alvotech.Hf（安沃泰克）合资建立的集靶向抗体药物研发、生产、销售于一体的高新技术企业,公司引进的6个品种均属于“重磅***”级别，2018年的销售额均超过20亿美元，其中阿达木单抗连续6年蝉联全球药王之位，2018年的销售额近200亿美元。公司2019年开始施工建设，建设周期2-3年，预计2022年***款产品上市，五年内实现两个产品上市，4个产品进入临床，同时适时启动公司的IPO。到2030年，估计营业收入可达60亿元、净利润15亿元、税金5亿元。
Changchun Alvotech &CCHN Bio-Pharmaceutical Co,Ltd.was founded in March 2019 by Alvotech Hf and Changchun High-tech Industry (Group) Co,Ltd, which had a registered capital of US $200 million. The company is located in Changchun Beihu Science and Technology Development Zone, China. Changchun Alvotech &CCHN Bio-Pharmaceutical Co,Ltd.is engaged in the research and development, production, sales in one of the high-tech JV.The six varieties introduced by Alvotech & CCHN all belong to the “ heavy bomb” class, with sales of more than $2 billion in 2018, of which adalimumab has been the world drug king for 6 consecutive years, with the sales of nearly $20 billion in 2018.Construction began in 2019, with a construction period of 2-3 years. Alvotech & CCHN's first product will be on the market in 2022, two products will be launched in the next five year, and the remaining four products will be in the clinical research stage. At the same time, company's IPO will be launched. By the 2030, it is conservatively estimated that revenue will reach to 6 billion RMB, net profit will be 1.5 billion RMB, and tax will be 500 million RMB.