J&J Family of Companies [Medical Devices] Sr. Regulatory Affairs Specialist in Yongsan-gu, South Korea
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.
포지션: Sr. Regulatory Affairs Specialist
계열사: 존슨앤드존슨 메디칼 (Medical Devices)
근무지: 서울시 용산구
Coordinates, compiles, and submits new product applications, abbreviated new product applications and investigational new product applications 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 for new product application and investigational new product applications.
1) Takes charge in products from certain franchises.
2) Prepares and submit required regulatory applications for new products and maintenance of existing products with limited supervision.
3) Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters with limited supervision.
4) Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.
5) Follows up of mandatory requirements for registration: local certificates, importation of samples and local testing, etc. with limited supervision.
6) Monitors and submit regulatory applications for changes of approved products with limited supervision.
7) Ensures Korean label contents and create and maintain Korean labels.
8) Researches and consolidate regulatory requirements and communicate their information with supervisor and manager.
9) Supports the RA team in projects.
10) Supports in the development of best practices for Regulatory Affairs processes.
11) Provides training and limited supervision of contract resources, as needed.
12) Conforms regulatory compliance.
13) Has a deep product knowledge of the franchise with responsibility.
1) Leverages a working knowledge of the regulatory environment to prepare compliant Regulatory strategies and scientific and technical understanding of medical devices to provide regulatory input to product life-cycle management and evaluate regulatory impact on products.
2) Provides suggestions on how to apply learning to develop new capabilities and leverage past challenges and experience in order to make decisions in ambiguous and changing situations.
3) Understands business environment and business strategies, and develops effective and results-oriented regulatory strategic plans that are in line with business objectives. Manages specific project steps to deliver required objectives independently/or with some supervision or as part of a team.
4) Understands the major trends in the healthcare environment, external marketplace changes, and competitors’ tendency and develops an understanding of the influence of social, economic and political factors on business and regulatory environment.
5) Effectively manages multiple competing priorities and collaborates with stakeholders with differing needs and view points in order to make the best possible decision. And consistently manages large amount of changing, complex, ambiguous information and makes timely and effective decisions for the execution of project objectives.
6) Engages with external stakeholders and demonstrates conviction, proactivity and persistence when influencing others and overcoming resistance. Creates compelling negotiating positions that builds support and consensus among key stakeholders. And builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels.
7) Delivers and creates oral and written technical communication with highlighting the most pertinent information for targeted stakeholders and leads to desired stakeholder actions.
8) Acts with speed, agility and accountability in the decision making and balances short and long-term decisions and activities. Demonstrates an enterprise-wide mindset.
9) Experiments and learns from trying new approaches and applying the new ideas generated by insights.
10) A minimum Bachelor’s degree is required.
12) Min. 3 years of progressive experience in Regulatory Affairs.
13) Knowledge of regulatory environment and relative law and regulations.
14) Understanding of regulatory requirements.
15) The incumbent must have the ability to work effectively with limited supervision and process requests/work within required timeframes.
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www.careers.jnj.com -> Requisition number 1700181421W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”
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Johnson & Johnson Medical Korea (Ltd.) (7225)