1) New product registration
- Communicating with regional RA to get the dossier in a timely manner
- Reviewing the dossier and submitting to MFDS with product information reflecting opinions from other departments
- Timely submission of supplemental documents requested by MFDS, if any
2) CMC variations of approved products
- Reviewing the dossier and submitting to MFDS in line with Q&C
- Timely submission of supplemental documents requested by MFDS, if any
3) Label updates
- Reviewing the documents forwarded from regional RA and submitting to MFDS
- Timely notification of label changes in accordance with appropriate SOP
4) Clinical trial application to MFDS
[ 제출서류 ] 국문.영문이력서.경력기술서 포함 (각종 증빙서류는 서류전형합격자에 한해 추후제출)
이메일: carly.lee@peoplework.co.kr******@*******.***
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