Associate RA Specialist
1개월전에
Description
- An internal pre-identified candidate has been found for consideration. However, all applications will be considered.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at .1.
포지션:
Associate RA Specialist
2.
계열사:
존슨앤드존슨 메드테크 (MedTech)
3.
근무지:
서울시 용산구
4.
근무 형태:
Fixed Term(12 months)
[Summary]
Coordinates, compiles, and submits applications of new products or changes to the approved products to the regulatory agencies. Assists with ensuring compliance with regulatory agency regulations and interpretations. Assists with the preparation of responses to regulatory agencies' questions and other correspondence. Assists with organizing and maintaining reporting schedules of new product registration, changes in products, projects, etc. Assists 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. Conducts searches of existing files for requested information. Maintains and archives all regulatory documentation.
[Responsibilities]
Functional and Technical Competencies
- Prepares, submits, and monitors applications of new products, changes in approved products, and KGMP with a certain degree of supervision.
- Interacts with regulatory agency personnel in order to expedite approval applications and to resolve regulatory matters with a certain degree of supervision.
- Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.
- Follows up of mandatory requirements for registration: local certificates, importation of samples, local testing, etc. with a certain degree of supervision.
- Ensures Korean label contents and approves the final Korean label artwork.
- Researches and consolidates regulatory requirements and actively communicates with the supervisor and the manager.
- Assists projects in the RA team and the enhancement for Regulatory Affairs processes.
- Conforms regulatory compliance.
- Understands business environment and business strategies and develops effective and resultsoriented regulatory strategic plans that are in line with business objectives. Manages specific project steps to meet milestones independently, with some supervision or as a part of the team.
- Understands the major trends in the healthcare environment, changes in external marketplace, and competitors' tendency and the influence of social, economic, and political factors on business and regulatory environment.
- Assists and supports others in interactions with external stakeholders and effectively influence others by partnering with them effectively. And develops internal and external networks that leads to opportunities to collaborate and learn.
- Develops verbal and written technical communications with guidance from others for the situation and audience and ensures common understanding by asking probing questions for active listening and conflict management.
- Makes decisions and prioritizes with guidance and helps from others to make timely and effective decisions and appropriate prioritization.
- Acts with speed, agility and accountability in the decision making and balances short and longterm decisions and activities. Demonstrates an enterprisewide mindset.
- A minimum Bachelor's degree
- Related RA experience in preferred.
- Strong communication and interpersonal skills
- Fluent in both verbal and written English
- Strives to acquire a deeper understanding of medical and scientific and technological developments.
접속 -> Position Number W검색 -> 해당 모집 공고의 "Apply Now" 클릭 후 온라인 지원 프로세스 진행
[제출 서류]
국&영문 자유 양식의 이력서/자기소개서
[서류 마감일]
8월 15일(목)
[유의사항]
- 국가 보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다.
- 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연될 수 있습니다.
- 입사 지원 서류에 허위 사실이 발견될 경우, 채용 확정 이후라도 채용이 취소될 수 있으며 향후 채용이 제한됩니다.
- 제출된 서류는 반환되지 않으며, 별도 요청 시 삭제합니다.
Qualifications
See above.
Primary Location Asia Pacific-South Korea-Seoul-Yongsan-gu
Organization Johnson & Johnson Medical Korea (Ltd
Job Function Regulatory Affairs
Req ID: W
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