注册申报主管/经理
Regulatory Affairs supervisor/manager
苏州
Suzhou
项目管理
project management
资历要求:
Requirement
  • 1、全日制本科及以上学历,药学或其他相关专业;

    Bachelor degree or above, pharmacy or other related majors;

  • 2、英语4级及以上水平,读写及流畅的口语沟通能力

    English CET-4 and above, literacy and fluent oral communication skills;

  • 3、年以上药品(生物药、原料药、制剂等)国内外法规注册经验;

    More than 3 years of domestic and foreign regulatory registration experience in pharmaceuticals (biological drugs, bulk drugs, preparations, etc.);

  • 4、对相关体系法规充分熟悉(如NMPA、FDA等),具有实际的国内外注册资料申报递交经验,对法规注册有深刻认识,能够有效指导公司法规注册相关工作;

    Experienced in regulations (such as NMPA, FDA,EMA etc.), have practical experience in submitting dossier to foreign registration, have a deep understanding of regulatory registration, and can effectively guide the company's regulatory registration related work;

  • 5、有好的项目管理能力、沟通能力、抗压能力。

    Have good project management ability, communication ability and anti-stress ability.

岗位职责:
Job Description
  • 1、全面负责公司产品注册申报相关工作;

    Fully responsible for the company's product registration;

  • 2、负责公司药品注册申报制度建设及符合性实施;

    Responsible for the construction and compliance implementation of the company's drug registration system;

  • 3、与项目团队合作,负责法规注册相关事务,包括:建立法规注册要求的文件体系,跟进了解药品监管部门的要求,

    Cooperate with the project team, and following up on the requirements of drug regulatory authorities,

  • 4、及时了解法规注册相关动态和政策调整,用以指导指定产品的法规注册工作;

    Keep up-to-date on the relevant developments and policy adjustments of the regulatory registration,

  • 5、对于法规注册要求的指定产品质量和数据完整性负责;

    Responsible for the specified product quality and data integrity required by regulatory registration;

  • 6、基于技术和法规注册相关知识,对公司发展战略和战略规划提出积极指导意见,鉴别和识别产品开发中存在的法规注册风险;积极参与技术研发工作,确保注册法规的可实施性;

    Based on the relevant knowledge of regulatory registration, provide positive guidance to the company's development strategy and strategic planning, identify risks in product development, and actively participate in research work to ensure the implementation of registration regulations;

  • 7、负责法规注册方面的培训工作,积极了解法规动态,对相关人员进行培训,为员工提供更广泛的指导;

    Responsible for training in regulations,and provide employees with guidance;

  • 8、组织并参与公司具体药品注册文件的编写和整理工作;

    Organize and participate in the preparation and organization of the company's specific drug registration documents;

  • 9、组织并参与公司药品注册过程中的各项现场核查准备工作。

    Organize and participate in various on-site inspection preparations during the company's drug registration process.

  • 联系人/Contact:

    Michelle Liu(刘)

  • 邮件/Email:

    HR@intellectivebio.com

  • 电话/Tel:

    15051555820