Johnson & Johnson
Regulatory Affairs Specialist
Seoul, Korea, Republic ofPosted 2 days ago
What you'd do
- Submit new product registration dossiers to MFDS and manage supplemental document requests
- Handle CMC variations of approved products and submit to MFDS in line with quality standards
- Prepare and submit label updates including CCDS revisions
What they want
- Bachelor degree or higher in pharmacy or equivalent healthcare training
- 1 to 3 years of pharmaceutical industry or medical environment experience
- Fluency in written and spoken English in addition to Korean
Nice to have
- Knowledge of Janssen Korea products and company SOPs
- Awareness of drug development principles and pharmacology