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Johnson & Johnson 职业机会

Ass. RA Manager-Energy

北京, 中国
Regulatory Affairs


Requisition ID: 1905734100W

  • Product registration related including new and renewal
  • Handling registration process, including
  • Document requirement
  • Dossier prepare
  • Submit to CFDA
  • Follow up evaluation procedure
  • Sample ordering, type testing
  • Solve various problems in whole process
  • File dossiers with consistent requirement
  • Ensure to obtain the regulatory permits on time, in support of the organization's business requirements
  • Having a good and consistent communication with local marketing and known well the business plan especially product launch plan
  • Establish working relationship with officials and experts in authorities, good communication and negotiation with officials and experts to guarantee smooth registration
  • Paying attention to the market information such as the competitors’ with the analysis
  • To coordinate the post market surveillance project
  • Supporting Chinese IFU /labeling, copy review for product related
  • Being involving into team working such as department meeting logistic arrangement
  • Maintain & Input database like: RA database, RTL…
  • Providing monthly report & analysis including latest registration status & post market surveillance
  • Develop Regulatory Strategy and Plan for Chartered R&D Initiatives from Sourcing Companies and Partner with the project team to ensure the approval at each review gate.

  • Medical or related education background and knowledge
  • 6~8 years experience in Regulatory Affairs
  • Good communication skill
  • Good time management
  • Well computer operating
  • Better English and Chinese in writing and oral

Regulatory Affairs
Requisition ID