Johnson & Johnson Careers

Ass. RA Manager-Energy

Beijing, China
Regulatory Affairs


Job Description

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.

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
1905734100W