北京招聘

1.     Regulatory project strategy up and planning for innovational drug development

2.     Lead and execute assigned project for regulatory activities including IND and NDA handling   

3.     Support BD from RA perspective about regulatory information, strategy and agreement/contract review

4.     Souring and vendor identification and management as per project needs

5.     Lead 1- 2 people team along with business growth

Target candidates

1. >10 years working experience on drug regulatory affairs

2. Experienced on handling for regulatory submission in different countries

3. Well know FDA and advance countries regulatory submission requirement

4. Experienced working with cross function R&D team in innovational drug companies

5. Skillful for regulatory strategy and project planning

6. Experienced working with CROs

7. Good English, good at planning, logic thinker

北海康成（北京）医药科技有限公司正式成立于2012年6月，总部设立在中关村望京科技创业园区内。
北海康成致力于解决满足“三个需求”，即满足中国患者对高效药物的需求、中国药企关键技术、产品更新换代的需求、发达国家中小生物制药企业进入中国市场的需求。
北海康成通过技术转让、吸收和再创新对接世界最大的生命高科技医药产品线与全球增长最快、潜力最大的应用市场。公司引进、研发、上市的重点是中国和亚洲市场所急需的特效药物。北海康成已经与欧美创新型生物制药公司、研究机构开展多个抗癌药物领域的技术合作。公司注重临床后期新药开发，有针对性地获取尖端的或国内新药研发所急需的制剂和生产工艺方面的成果，通过再创新和技术转化研发上市拥有自主知识产权的医药产品。