南京招聘

Major Accountabilities

Review, compile, and submit IND, CTA, BLA applications, supplements and amendments;

Provide regulatory inputs for new project development strategy discussion;

Accountable to supervise the direct reports on the implementation of the project regulatory strategy by projects planning and tracking, and project executions;

Accountable for achieving the target timeline of submission and approval; Accountable for the communication with Health Authorities (HAs) to properly address the concerns on projects; and the coordination of related HA meetings;

Maintain a good relationship with HAs; Communicate with internal cross functional team on the related regulatory issues on the responsible projects;

Accountable to provide regulatory support to other functional team;

Accountable for ensuring regulatory compliance for the responsible project-related activities, like, maintenance of CTA-related submissions, and give input to relative WIs or SOPs updates;

Monitor regulatory changes and report to department head timely;

Provide/Assist department head to coach the junior levels; Other appointed tasks.

Job Profile(Education & Experience)

Education: Bachelor or above with Pharmaceutical/Medical/Science background

Languages: Fluency in English and Chinese (oral and written)

Experience: At least 8 years of life science industry experience post bachelor’s degree, with at least 5 years of demonstrated accomplishment in RA field; Or at least 5 years life science industry experience post Master’s degree; Or at least 2 years life science industry experience post Doctor’s degree;

The experience in filing and obtaining approval for local or global trial IND/CTA independently;

Skills of cross functional communications within the company; Experience in HAs interactions;

Experience with SOPs and WI updates; Experience in biologics such as mAb product submission is a plus; Experience with electronic submission is a plus; Experience with CRO management is a plus;

The experience in filing and obtaining NDA/BLA approval is a plus.

    复宏汉霖（*******）是一家国际化的创新生物制药公司，旨在为全球患者提供质高价优的创新生物药，产品覆盖肿瘤、自身免疫性疾病等领域。自2010年成立以来，公司以全球联动、整合创新为产品开发理念，在中国上海、中国台北和美国加州均设有研发中心，具备了协同增效的突出优势。复宏汉霖主要的产品开发策略是仿创结合，从生物类似药起步，逐步开发创新型单抗产品，结合自主开发的抗PD-1和PD-L1单抗，在国内率先推出免疫联合疗法，前瞻性布局了一个多元化、创新单抗及肿瘤免疫联合疗法管线，打造出研究、开发、商业化生产的综合性生物医药全产业链平台。

    截至目前，复宏汉霖已有1个产品成功上市，2个产品获得中国新药上市申请受理，1个产品获得欧盟营销授权申请受理，10个产品、8个联合治疗方案在全球范围内开展20多项临床试验。其中，公司首款重磅产品汉利康？（利妥昔单抗注射液）于2019年2月获国家药监局新药上市注册批准，成为中国***获批上市的生物类似药。HLX03（阿达木单抗注射液）与HLX02（注射用曲妥珠单抗）已获国家药监局新药上市申请受理，现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验，成为国内***开展国际多中心3期临床研究的生物类似药，并于2019年6月获欧洲药品管理局营销授权申请受理。此外，公司已陆续就HLX10（抗PD-1单抗）与自有产品HLX04（贝伐珠单抗生物类似药）、HLX07（抗EGFR单抗）以及化疗联用开展多项肿瘤免疫联合疗法，在全球范围内开展多个临床研究。