Regulatory Affairs StaffID:24514

-HanoiOver 3 months ago

Overview

  • Salary

    -

  • Industry

    Manufacturing(Pharmaceutical/MedicalEquipment)

  • Job Description

    【Job Summary】
    - Responsible for regulatory affairs activities

    【Main responsibilities
    - Perform tasks to ensure that the activities of the regulatory affairs department are carried out in accordance with the legal requirements of regulatory affairs regulations.
    - Ensure that the regulatory affairs process is conducted on time and meets the Company's requirements.
    - Build and maintain relationships with drug regulatory agencies and related organizations.
    - Develop and implement strategies and plans to execute the regulatory affairs process efficiently and promptly.
    - Comply with procedures and quality standards related to regulatory affairs documents.

    【Company/Job Attraction】
    - Professional and friendly work environment, opportunities for career development.
    - Participation opportunities in high-quality drug registration processes.
    - Opportunities for advancement within the company and involvement in significant projects.
    - Training and enhancement of professional and management skills.

Qualifications

  • Requirement

    <Must>
    - Graduated from university with a major in pharmacy or related fields.
    - At least 2 years of regulatory affairs experience
    - Knowledge of regulatory affairs procedures and regulations of drug administration.
    - Understanding of quality management procedures and legal requirements related to regulatory affairs documents.
    - Good communication in Japanese (from N3 advance).
    - Good communication and persuasive skills with stakeholders, ability to build strong relationships.
    - Attention to detail, excellent organizational and time management skills

    <Prefer>
    - Experience working in pharmaceutical companies or drug administration.

  • English Level

    Doesn’t matter

  • Other Language

    None

Additional Information

  • Benefit

    -13 month bonus
    -Company trip
    -Parking fee
    -Gasoline fee
    -Social insurance & medical insurance(related to Vietnamese law)
    -12 days paid leave(if CDD kept belonging more than 5 years, the paid leave will increase such as 13 days)

  • Working Hour

    8:00 ~ 17:00

  • Holiday

    Sat, Sun, Holiday
    *But if have the event on the weekend, cdd need to come to support. Overtime will be covered by replacement leave.
    Ex: Sports event

  • Job Function

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