Johnson & Johnson Careers
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[Consumer] Sr. RA Specialist
Requisition ID: 1805633722W
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
2. 계열사: 존슨앤드존슨 컨슈머 (Consumer)
3. 근무지: 서울시 용산구
· Support launching new product registration and maintaining current products in compliance with regulation.
· External environmental influence on behalf of company’s position. Monitoring regulation changes and inform to relevant functions.
· Manage the activities concerned with regulatory action to government regulatory agencies for OTC, Quasi drug, cosmetics, etc.
· Establish and communicate the regulatory strategy for new product launch and any variation for current marketed product
· Communicate and manage the regulatory compliance matters with government regulatory agencies & internal stakeholders
· Oversees or prepare & maintain the regulatory submissions and files and communication with agencies
· Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
· Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters
· Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals
· Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines
· Review and advice the regulatory review for artwork and advertisement materials
- Bachelor’s degree and above
- More than 5 years experience in Regulatory Affairs
- Technical knowledge in Chemistry, Chemical engineering or Pharmacy
- Good leadership (Communication, Collaboration, Problem Solving, Project Management)
- Proactive, Positive and Innovative mindset
- Networking with external stakeholder specially in MFDS, Trade association
- Good English Communication (Writing & Verbal)
ohnson & Johnson Korea Sales & Distribution LLC (7227)