长沙招聘

职位描述：
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 medical devices，drugs and biologicals. 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 举报 分享

药明康德是国际领先的开放式能力与技术平台公司，为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任，以客户为中心的宗旨，药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等，正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目，致力于将最新和***的医药和健康产品带给全球病患，实现“让天下没有难做的药，难治的病”的梦想。