Johnson & Johnson Careers

Assistant RA Manager-Joint

Beijing, China
Regulatory Affairs


Job Description

Requisition ID: 1905738340W

  • Product registration related including new and renew
  • 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

Qualifications
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
Primary Location
China-Beijing-Beijing-
Organization
Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function
Regulatory Affairs
Requisition ID
1905738340W