北京招聘

Responsibilities:

1. Responsible for all regulatory activities of the HBM products in China, including IND/MRCT submissions, ongoing interactions/follow-up/supplemental submissions, with competitive timeline and high quality.

2. Closely follow up the changes to the regulatory environment

3. Responsible to ensure full compliance to the regulatory requirements.

4. Develop & maintain the good relationship with regulatory authorities, especially the CFDA

5. Support internal R&D projects & clinical DD projects with timely, precise regulatory assessment.

Qualifications and Requirements (degree, certifications, etc. and other requirements):

• Bachelor degree on medical, pharmacy, pharmacology, biochemistry or chemistry
• Master or PhD is plus

• Extensive regulatory experiences with commercial business principle, minimum 6-9 years working experiences in regulatory affairs function of pharmaceutical company.

• Experience with China Regulatory affairs and CFDA process

• Possess a high degree of honesty with a track record built on success stories and sound ethics, have a proven track record from a pharmaceutical company.

• Fully understand the current regulatory practices and regulation in China, the authority structure and relationship among different regulatory bodies, knowing and building the relationship with some key customers.

• With tract record on successful filing for innovative products in China

• Able to work with a keen sense of urgency and priority, task oriented with a “Big Picture” approach.

• Excellent verbal and written communication skills and good enough English, fluent in English reading/writing/listening/speaking.

• Good project management skill and experience.

• Excellent verbal and written communication skills and good enough English, fluent in English reading/writing/listening/speaking.
• Good at PC skills on Word, Excel, PowerPoint, Outlook, MS Project

和铂医药是一家专注于肿瘤免疫领域创新药物研究与开发的全球化运营生物医药公司。公司将运用其拥有的全部自主知识产权的全人源单抗的转基因鼠系列核心技术平台，建立下一代治疗性肿瘤抗体药物产品管线,并将围绕Harbour的两大平台拓展合作与授权业务。公司总部及研发基地位于中国上海，另外在美国马塞诸塞州剑桥设立商业运营中心，在荷兰鹿特丹设立抗体研发平台创新中心，在波士顿地区设立了创新中心包括实验室和研发团队，也将在江苏昆山设立研发基地。公司拥有资深管理团队以及丰富的药物研究与开发经验。和铂医药要为满足中国及全球病人的需求而不断努力，依托拥有自主知识产权的核心技术平台,创建一个在肿瘤治疗领域有科学与技术领导力的国际性生物医药公司。同时, 在药物研发领域建立以技术平台为基础的对外合作，整合新的技术，推动中国整个抗体研发产业的进步。

Company Overview
Harbour BioMed is a global biotechnology company discovering and developing innovative therapeutics for cancer with a focus on immuno-oncology and autoimmunity/inflammation. The company's discovery and development programs are centered around its two patented transgenic mouse platforms for human antibody discovery.
The company is building its proprietary pipeline internally, through collaborations with co-development partners, as well as through selective preclinical and clinical stage asset acquisitions. Harbour BioMed also licenses the platforms to companies and academic institutions through its Harbour Antibodies subsidiary.
Harbour BioMed has headquarters and an R&D site in Shanghai, business operations in Cambridge, MA, and antibody platform development in Rotterdam, The Netherlands.
The company has an innovation center including research lab and a development team in Boston. Also, we are expanding to Kunshan site in Jiangsu for our R&D operation.