[Required skills & Competencies]

• Actively communicate with Korean regulatory government (APQA) and follow up the product registration, variation, re-assessment, PMS, and other APQA leading major activities
• Review and translate regulatory dossiers and complete product registration
• Strive to generate the local regulatory dossier for submission / communication / registration
• Conduct product registration Project – Connect various Company regulatory systems (Veeva vault, Sharepoint, ETS, SAP, LMS etc) and get the required document and actively follow up related to the product registration
• Communicate with 3rd party lab for product changes and variations and review pharmaceutical test method changes
• Communicate with APQA &  3rd party lab for registration & variation of national lot release test.
• Attend various teleconference related to the regional meeting and actively participate in case the Korean project issued.
• Manage major project timeline and report / control the expenses related to the regulatory project
• Connect University or 3rd party local test CRO for local study which is required for product registration
• Participates and contributes as a team member. Takes responsibility for a portion of the team’s milestones/deliver-ables.
• Exercises judgment utilizing breadth of knowledge and prior work experience.
• Artwork : Manage updates to local regulatory documents pertaining to manufacturing site, label or specifications changes (name, style, contents, etc.) driven by globally or locally required changes
• Review for Promptional materials according to regulations Review and advice the regulatory review for the artwork and advertisement materials
• Pharmacovigilance :  Management of PV of marketed product. Ensure compliance with all global PV requirements and all local regulations, together with identification of suitable risk management plan.

[업무내용]

• 제품등록, 평가, 인증, PMS 등 식약처/농림축산검역본부 대관 업무
• 제품등록을 위한 프로젝트 관리 및 RA 업무 전반 (문서 관리, 제출, 소통)
• 약제감시 역할 수행(시판제품 PV 관리), 글로벌/한국 규제 준수 및 리스크 관리
• 제품 변경에 대한 의약품 테스트 방법 리뷰 및 연구기관 소통

• Education: 수의학, 약학, 생물 생명 화학 축산 관련 전공
• Experience: 동물 및 인체의약품 등 RA / 등록업무 5년이상
• License: 약사 / 수의사 자격증 (preference)
• Language Skill: Native Korean, Moderate in reading & writing / speaking in English
• Others: 농림축산검역본부/식약처 대관 업무 경력

[근무조건]

• 1년 계약직(육아휴직 대체)
• 근무부서: RA/QA
• 복리후생: 법정 연차 별도 여름휴가(5일), 주 1회 재택근무, 단체보험 지원, 경조사 지원, 본인/가족 의료비 지원, 자녀학자금 지원(유치원 이상), OT 가산수당 제도, 식대 지원 등