(Senior) Manager, Regulatory Affairs - Solid Tumor

Johnson & Johnson

4.2

Beijing, China

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020

  • 4.2/5 in overall job satisfaction

  • 4.3/5 in supportive management

  • 71% say women are treated fairly and equally to men

  • 88% would recommend this company to other women

  • 84% say the CEO supports gender diversity

  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).

  • Global exercise reimbursement.

  • Two weeks off (one of them fully paid) for volunteer work.

  • #2306123500W

    Position summary

    Summary of Job Responsibilities:

    • Responsible for the registration of certain indications (Mono, or Combo per study) under the product scope of Oncology (solid tumor TA).
    • Closely connection with regional and global stakeholders to development competitive registration strategy
    • Lead HA interaction, ensure NDA/BLA timely filing and response to HA queries.
    • Lead for in country QC testing to support the Filings.
    • Provide mentoring and coaching to junior staff members.
    • Keep good relationship with authority and key stakeholders.
    • Perform with high quality and compliance 

    Dimensions of Job:

    • Support new pipeline for Business growth
    • Coaching Team members and Continuously contribute team’s performance improvement.

    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

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    What are Johnson & Johnson perks and benefits

    Child care benefits

    Paid maternity

    Unpaid maternity

    Paid paternity

    Unpaid paternity

    Paid adoptive

    Short term disability

    About the company

    Industry: Consumer Packaged Goods: Packaged Products
    By caring for the world one person at a time, we aspire to help billions of people live longer, healthier, happier lives. This aspiration inspires and unites the approximately 127,100 employees of Johnson & Johnson across more than 250 operating companies in 60 countries. We embrace research and science, bringing innovative ideas, products and services to advance the health and well-being of people. For 130 years, the Johnson & Johnson Family of Companies has been committed to caring for people around the world.

    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020

  • 4.2/5 in overall job satisfaction

  • 4.3/5 in supportive management

  • 71% say women are treated fairly and equally to men

  • 88% would recommend this company to other women

  • 84% say the CEO supports gender diversity

  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).

  • Global exercise reimbursement.

  • Two weeks off (one of them fully paid) for volunteer work.