[ 담당업무 ]

• 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
  - Communicating with GCO and regional RA to get the dossier in a timely manner
  - Reviewing the dossier and submitting to MFDS
  - Timely submission of supplemental documents requested by MFDS, if any

[ 자격조건 ]

Bachelor degree in Pharmacy or related scientific discipline; postgraduate qualifications in business or related areas will be an advantage
Minimum of 3-year experience in Regulatory Affairs in pharmaceutical industry

[ 전형방법 ]

1차 서류전형 /2차 면접전형

[ 제출서류 ] 

국문.영문이력서.경력기술서 포함 (각종 증빙서류는 서류전형합격자에 한해 추후제출) 

이메일: carly.lee@peoplework.co.kr******@*******.*** 

채용담당 : 이경아 전무 ( ***-****-****/ ***-****-****)