[한국조에티스] Regulatory Affairs Specialist 채용

JOB TITLE: RA Specialist

JOB TYPE: Regular

DEPARTMENT: Regulatory Affair & Quality Assurance

POSITION REPORTS TO: Regulatory Specialist

1. PURPOSE OF POSITION/ROLE

ㅁStrive to register Zoetis Product and take relative action toward Korean regulatory (APQA) guideline

2. KEY ACCOUNTABILITIES AND RESPONSIBILITIES  

ㅁActively communicate with Korean regulatory government (APQA) and follow up the product registration, variation, re-assessment, PMS, and other APQA leading major activities

​ㅁReview and translate regulatory dossiers and complete product registratioN

ㅁ​Strive to generate the local regulatory dossier for submission / communication / registratio

ㅁ​Conduct product registration Project – Connect various Company regulatory systems (VyPER, Veeva vault, Sharepoint, ETS, SAP, LMS etc) and get the required document and actively follow up related to the product registratio

ㅁ​Communicate with 3^rd party lab for product changes and variations and review pharmaceutical test method change

ㅁ​Attend various teleconference related to the regional meeting and actively participate in case the Korean project issued

ㅁ​Manage major project timeline and report / control the expenses related to the regulatory projec

ㅁ​Connect University or 3^rd party local test CRO for local study which is required for product registration

ㅁ​Participates and contributes as a team member. Takes responsibility for a portion of the team’s milestones/deliver-ables

ㅁ​Exercises judgment utilizing breadth of knowledge and prior work experience

​3. SKILLS, KNOWLEDGE, QUALIFICATIONS AND EXPERIENCE

ㅁEducation:  수의학, 약학, 생물/축산 관련전공자

ㅁ​Experience:  동물약품 RA QA 근무자 우대 / 등록업무 3년이상 경력자 우대

ㅁ​License: 약사 / 수의사 자격증 소지자 우대

​ㅁLanguage Skill: Native Korean, Moderate in reading & writing / speaking in English

ㅁOthers: 농림축산검역본부/식약처 대관 업무 유경험자 우대