Project Manager, Regulatory Affairs

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Beijing, China

Job Description:

Principal Duties and Responsibilities (General Summary, essential functions and authorities, etc.)

        主要工作职责（基本概况，主要功能，权限等）


* Align with company and commercial strategy, direct, develop and manage project registration activities focused on the define registration (and renewal) strategy, registration project plan, supervision on project execution and delivery.

   基于公司和业务策略，指导、开发和管理项目注册工作，着重于制定注册（和延续注册）战略、注册项目计划，监督项目执行与交付。


* Manage day-to-day operation to ensure registration related projects/programs progress.

Review and approve required information for the registration dossier and technical requirement document.


*

   管理日常运营，以确保注册相关项目/计划的流程妥善实施。审批注册资料和技术要求文件所需信息。



* Assign and allocate resources and actively oversee departmental (team) projects.

Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.

   分配和配置资源，积极监督部门（团队）项目。给指定团队提供管理层面的引导与指导，允许适当的资源优化配置以实现目标。


* Interact and proactively forge new relationships with external partners, including global regulatory functions, quality, R&D, manufacture and commercial partners, Effectively communicates with franchise and local cross functional leaders.

   与公司外部合作伙伴，包括全球法规部门、质量、研发、生产和商业伙伴互动并积极建立新关系。和总部及当地跨职能部门负责人有效沟通。


* Establish and maintain relationship with NMPA and other authorities, manage and maintain clear and effective internal-external communication channel.

   与NMPA以及其他监管部门建立并维持良好关系，管理并维护内-外部之间的有效沟通渠道。

   Provide regulatory support for cross functional departments and cultivate company regulatory compliance environment.

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