Regulatory Affairs StaffID:24514
-Hanoi3ヶ月以上前概要
給与
-
業界
Manufacturing(Pharmaceutical/MedicalEquipment)
仕事内容
【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.
求めている人材
応募条件
<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.英語
Doesn’t matter
その他言語
None
その他
福利厚生
-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)就業時間
8:00 ~ 17:00
休日
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職種
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