Regulatory Affairs ManagerID:24515

-HanoiOver 3 months ago

Overview

  • Salary

    -

  • Industry

    Manufacturing(Pharmaceutical/MedicalEquipment)

  • Job Description

    【Job Summary】
    - Responsible for managing the Regulatory Affairs Department

    【Main responsibilities
    - Lead and manage the Regulatory Affairs Department, ensuring department operations comply with legal requirements and company standards.
    - Ensure drug registration processes are completed on time and meet legal requirements.
    - Engage in building relationships with drug regulatory agencies and related organizations.
    - Develop strategies and plans to ensure efficient and expedient drug registration processes.
    - Ensure compliance with procedures and quality standards related to drug registration documents.
    - Provide creative and optimized solutions to enhance efficiency and competitiveness in drug registration processes for the company.

    【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 3 years of experience in regulatory affairs management
    - Understanding of regulatory affairs procedures and regulations of drug administration.
    - Knowledge of quality control procedures and legal requirements related to regulatory affairs documents.
    - Specialized English proficiency and Japanese conversation
    - Strong leadership skills, team management ability, and ability to work independently.
    - Excellent communication and persuasion skills to build relationships with stakeholders.
    - Attention to detail, strong organizational skills, and good time management.

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

  • English Level

    Upper-Intermediate Level

  • 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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