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[Á¸½¼¾ØµåÁ¸½¼ ¸ÞµðÄ®] Sr. Regulatory Affairs Specialist
http://careers.jnj.com
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Consumer, Pharmaceutical, and Medical Devices
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Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
1. Æ÷Áö¼Ç: Sr. Regulatory Affairs Specialist
2. °è¿»ç: Á¸½¼¾ØµåÁ¸½¼ ¸ÞµðÄ® (Medical Devices)
3. ±Ù¹«Áö: ¼¿ï½Ã ¿ë»ê±¸
4. ±Ù¹« ÇüÅÂ: Regular
[Summary]
Coordinates, compiles, and submits mainly license change (incl. product change) applications. Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines. Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides. Provides solutions to a variety of problems of moderate scope and complexity. Organizes and maintains reporting schedules for license change (incl. product change) applications.
[Responsibilities]
1. Takes charge in products for assigned projects.
2. Prepares and submits required regulatory applications for new products for replacement, change of manufacturing process
3. Monitors and submits regulatory applications for changes of approved products
4. Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters
5. Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.
6. Follows up of mandatory requirements for registration: local certificates, importation of samples and local testing, etc.
7. Researches and consolidate regulatory requirements and communicate their information with supervisor and manager.
8. Supports the RA team in projects.
9. Supports in the development of best practices for Regulatory Affairs processes.
10. Conforms regulatory compliance.
11. The incumbent must have the ability to work effectively and process requests/work within required timeframes.
12. A team player with a diligent and sincere attitude and mindset
13. Has a strong sense of responsibility on meeting due/target and quality/integrity/accuracy of the output
14. Views new and ambiguous challenges as a learning opportunity
[Requirements]
- A minimum Bachelor¡¯s degree is required.
- Min. 4 years of progressive RA experience in HealthCare industry.
- Knowledge of regulatory environment, relative law and regulations on Medical Devices.
- Understanding of regulatory requirements.
- Good at writing and translation skill in English
- Prefer holding a Regulatory Affairs Certification (RAC)
- Expert in MS Word, Excel, Power Point and HWP etc.
[Áö¿ø ¹æ¹ý]
www.careers.jnj.com Á¢¼Ó -> Position Number
2105901392W
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[For more J&J Korea Information]
ÆäÀ̽ººÏ ä¿ë ÆäÀÌÁö:
https://www.facebook.com/JNJCareersKorea/
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https://www.linkedin.com/company/johnson-&-johnson/
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