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
4. 근무 형태: Regular
[Summary]
- Proceed the regulatory action of OTC product in compliance with regulation for new product launch and maintenance
- Manage the internal compliance process for OTC product including change control, AW development, etc.
[Responsibilities]
- Manage the activities concerned with regulatory action to government regulatory agencies for OTC/Cosmetic/Quasi Drug
- 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
- Prepare & maintain the regulatory submissions and files and communication with MFDS
- Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters
- Consult with management personnel to establish and prepare appropriate regulatory filings for product approvals
- Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines
- Review and advice the regulatory review for artwork and advertisement materials
[Requirements]
- Bachelor’s degrees or above.