长沙招聘

General Summary

• Provides technical knowledge and support of clinical trials applications, regulatory requirements for study start up, marketing-authorisation applications, and license maintenance for both internal customers and external clients related to drugs, biologicals and medical devices. Primary job responsibilities include the preparation of regulatory submissions to support clinical trial application, new drug application, abbreviated new drug application, supplemental applications.

• Monitor the regulations and regulatory trends for healthcare and pharmaceutical products.

• May participate in project teams and may lead specific regulatory tasks, under the guidance of senior staff.

• May assume responsibility for direct communication of project specifics to external client upon the approval of senior staff.

Accountabilities

• Execute regulatory plans/strategies and prepare registration dossier and ensure timely submission, in compliance with regulations, guidelines and SOPs.

• Track project progress timely and communicate with regulatory agencies/institutes on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing. Resolve any issue timely to ensure earliest possible registration, consulting senior staff, as necessary.

• Continuously monitor the new regulations and regulatory trends of healthcare and pharmaceutical products, and ensure the potential impact to projects or company business have been thoroughly well communicated.

• Interact with internal clients. May have some external interactions when directed by senior staff.

• Support senior staff in managing client requests.

• May make decisions on or develop new processes for specific tasks, consulting senior staff, as necessary.

Qualifications

• Undergraduate degree or above in medical science or related life sciences area.

• Over 1 year (specialist) or 2 years (senior specialist) of regulatory experience or product development.

• Be familiar with regulations and guidelines of CFDA, FDA, EU, and ICH.

• Excellent communication skills and convincing skills in both Chinese and English.

• Must have careful attention to detail and accuracy.

• Must be able to collaborate with others and work independently with appropriate direction.

• Open attitude and willing to meet challenges.

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务，包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册，通过严格的质量控制体系和专业团队的丰富经验，帮助创新性，突破性医药产品尽快上市和造福患者。

康德弘翼立足中国，面向世界，以上海总部为中心，辐射全球制药公司、生物技术公司以及医疗器械公司。目前，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系，始终保持着紧密的业务交流，保证了项目能高效、高质地完成。

随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。