南京招聘

  

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 strategy/plan, the preparation and coordination of submissions to support clinical trial application, new drug application, abbreviated new drug application, supplemental applications, etc.

• Provide regulatory expertise to the products’ research and development.

• Supports business development efforts.

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

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

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

            

  

Accountabilities

  

• Develops or reviews regulatory strategy and action plan for internal or external projects.

• Provides advises, consults in the area of expertise both internally and to clients.

• Prepares or reviews regulatory dossier and ensure timely submission, in compliance with regulations, guidelines and SOPs. Resolve any issue timely to ensure earliest possible registration.

• Keeps abreast of current data, trends, regulatory knowledge, developments and advances in the China and global regulatory environment. Ensure any potential impact to projects or company business have been thoroughly well communicated.

• Manages and coordinates resources and reviews workload for all direct reports. Guide and support staff to improve knowledge and skill continuously. Reviews performance and provide counseling for direct reports

• Provides support to Business Development

• Interacts with internal and/or external clients. Identifies and responds appropriately to issues, providing adequate and/or innovative solutions.

• Identifies project needs and scope of work, creates project timelines and implements client requests, seeking clarification and senior review, as necessary.

• Works with minimal direction, identifies project needs, creates project timelines, and tracks project budgets (where appropriate) for multiple projects and revises and manages scope of work changes, when necessary.

• May serve as Project Manager or technical lead on a regulatory project.

• Build up and sustain a reliable and professional relationship with regulatory authorities (e.g., CFDA, CDE, NICPBP, Provincial FDAs, Drug Control Institutes).

                      

  

  

  

Qualifications

  

• Undergraduate degree or above in medical science or related life sciences area. Over 6 years of regulatory experience in a global leading pharmaceutical company or CRO.

• Ability to exercise independent judgment in developing effective resolutions to problems in a regulated environment.

• Must demonstrate abilities in scientific knowledge and its appropriate application to regulatory issues.

• Extensive knowledge of regulations relevant to the area of expertise.

• Ability to work on several projects at once while balancing multiple timelines (i.e., overlapping timelines on one or more projects).

• Ability to communicate effectively in both oral and written modes.

• Ability to communicate at multiple levels in the organization and in difficult situations.

• Must have careful attention to detail and accuracy.

• Open attitude and willing to meet challenges.

• Must possess strong negotiating skills.

                    

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。