[MedTech] Sr. RA Specialist - SPECIAL PROJECTS
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. 포지션: Sr. RA Specialist - SPECIAL PROJECTS
2. 계열사: 존슨앤드존슨 메디칼 (MedTech)
3. 근무지: 서울시 용산구
4. 근무 형태: Regular
Coordinates, compiles, and submits applications of new products or changes to the approved products to the regulatory agencies. Ensures compliance with regulatory agency regulations and interpretations. Prepares responses to regulatory agencies' questions and other correspondence. 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 of new product registration, changes in products, projects, etc..
Functional and Technical Competencies
1. Prepares, submits, and monitors applications of new products, changes in approved products, and KGMP.
2. Applies knowledge in regulations and characteristics of products to prepare compliant regulatory strategies and to assess regulatory impact on products as product life-cycle management.
3. Interacts with regulatory agency personnel in order to expedite approval applications and to resolve regulatory matters with limited supervision.
4. Follows up of mandatory requirements for registration: local certificates, importation of samples, local testing, etc. with limited supervision.
5. Ensures Korean label contents and approves the final Korean label artwork.
6. Researches and consolidates regulatory requirements and actively communicates with the supervisor and the manager
1. Effectively manages priorities and strongly collaborates with stakeholders to make the best possible decision. Consistently manages large amount of changing, complex, ambiguous information and makes reasonable decisions in a timely manner.
2. Engages with external stakeholders and demonstrates conviction, proactivity, and persistence especially when influencing others and overcoming resistance. Creates compelling positions in negotiations that build support and consensus with key stakeholders. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels.
3. Creates and delivers verbal and written communication with highlighting the most pertinent information for targeted stakeholders. Supports stakeholders to take actions if needed.
- A minimum Bachelor’s degree
- Min. 5 years of experience in Regulatory Affairs
- Understanding in regulatory requirements, laws, standards, and environment
- The incumbent must have the ability to work effectively with limited supervision and process requests/work within required timeframes
- Strong communication and interpersonal skills
- Experience in a multi-national or regional company is preferred
- Fluent in both verbal and written English
www.careers.jnj.com 접속 -> Position Number 2306140707W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행
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