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Regulatory Affairs Group

Senior Manager, Regulatory Affairs - Solid Tumor

  • 标题 Senior Manager, Regulatory Affairs - Solid Tumor
  • 功能 Regulatory Affairs Group
  • 子功能 Regulatory Affairs
  • 工作地 Beijing, China; Shanghai, China
  • 发布时间
  • 申请ID 2306157857W
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描述

Summary of Job Responsibilities:
1.    Responsible for the registration of certain indications (Mono, or Combo per study) under the product scope of solid tumor TA. 
2.    Closely connection with regional and global stakeholders to development competitive registration strategy
3.    Lead HA interaction, ensure NDA/BLA timely filing and response to HA queries.
4.    Lead for in country QC testing to support the Filings.
5.    Provide mentoring and coaching to junior staff members.
6.    Keep good relationship with authority and key stakeholders.
7.    Perform with high quality and compliance 

Dimensions of Job:
1.    Support new pipeline for Business growth
2.    Coaching Team members and Continuously contribute team’s performance improvement.

Principal Accountabilities of Job:
1.    Cooperate with global, regional, local compound team and Cross Function to establish registration plan and strategy.
2.    Good communication skill.
3.    Interact with HA division level and above.
4.    Actively involve into establishment and revision of regulations, guidelines.
5.    Develop internal SOPs and working instruction.
6.    Own work-related knowledge on device regulations. 
7.    Credo based behavior with compliance manner.

Key Performance Measures: 
1.    Regulatory strategy and timeline consistency
2.    Qualitative delivery without critical finding 
3.    Good HA connection 
4.    Others:  Crisis management, people development, as active contributor in some policy work

资格

1.    A Bachelor’s degree or above, major in a related life-science discipline. 
2.    > 8 years of regulatory affair experience in a multinational pharmaceutical company. 
3.    Strong lobby/negotiation capability and excellent communication skill; excellent leadership with team spirit; high learning ability and willing to work under high pressure.
4.    Have good communication with HA.
5.    Fluent English in verbal and written; good computer skill, good presentation skill.
6.    Rich Experience in New Compound registration is needed, and the regulatory experience in Oncology Therapeutic Area is preferred.

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