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Regulatory Scientist

Location: 

Shanghai, Shanghai, China

Job Function:  Regulatory Affairs
Job ID:  64099
  • Establish networks with NMPA/CDE and industry associations
  • Lead key topics of interest to UCB internally and externally as part of shaping the environment
  • Collect, analyse and provide impact analysis based on emerging regulatory intelligence
  • Shepherd documents through internal process for guideline commenting and input
  • Communication of Regulatory Intelligence including impact analyses
  • Establish and maintain strong interfaces with Health Authorities
  • Drive and shape UCB policy and environment in efforts push value to patients and drive business
  • Provide expertise to teams to ensure NMPA/CDE needs and requirements are understood and met where appropriate
  • Work in a matrix environment
  • Responsible for developing credible and trustful relationships internally and externally
  • Provide strategic regulatory strategy based on the  emerging regulatory intelligence
  • Takes a long-term view and makes plans for acquiring the skills and expertise needed to support the business today and in the future
  • Provide competitive intelligence to stakeholders
  • Participate RDPAC and other task forces and to bring important learnings to UCB
  • Author white papers, slides based on major regulations and intelligence periodically
  • Participate in the execution of projects necessary to achieve affiliate company goals and corporate objectives
  • Determine and authorize RA strategies in line with UCBC/ global RA (GRA) strategies of post marketing products for local and global products
  • Ensures timely sharing of the important RIs
  • Accountable for the assigned tasks within the RA team
  • Shapes regulatory environment by active participation at HA meetings, when required
  • Ensure Regulatory Compliance for the affiliate (U pilot, MIKADO,SOPs)
  • To be responsible for interactions and negotiations with regulatory bodies in China


Job Segment: Regulatory Affairs, Scientific, Medical, Scientist, Law, Legal, Engineering, Healthcare, Science

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