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(Senior) Manager, Regulatory Affairs - IDV&Retinal



Beijing, China
Posted on Friday, May 26, 2023


Summary of Job Responsibilities:

  • Responsible for the regulatory affair for IDV & Retinal TA
  • Closely connection with local and global stakeholders to development competitive registration strategy
  • Represent RA and provide regulatory strategy input for China compound teams; execute CTA & NDA/BLA filings; lead CDE consultation preparation activities and meeting minute’s preparation.
  • Lead for in country QC testing to support the Filings.
  • Establish strong relationship with regulatory authority and key stakeholders in the local, regional and global organization.
  • Perform with high quality and compliance

Dimensions of Job:

  • Support new pipeline for Business growth
  • Regulatory LCM strategy support for responsible marketed products, as well as input to BU and product teams

Principal Accountabilities of Job:

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

Key Performance Measures:

  • Regulatory strategy and timeline consistency
  • Qualitative delivery without critical finding
  • Good HA connection
  • Others: Crisis management, people development, as active contributor in some policy work


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