JANSSEN] RA SPECIALIST

At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in pharmaceutical, medical devices and diagnostics markets, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
nj.
om/.
1.
Position.
RA Specialist 2.
Sector.
Janssen (한국얀센) 3.
Location.
Yongsan-gu, Seoul 4.
Work Type.
Regular To register products in a timely manner in support of business growth and to maintain full compliance of products with regulatory requirements [Job scope] New product registration CMC variations of approved products Label updates (including CCDS update) Clinical trial application to MFDS Support of regulatory activity in license management [Key Accountability] 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 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 Label updates -- Reviewing the documents forwarded from regional RA and submitting to MFDS Timely notification of label changes in accordance with appropriate SOP 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to MFDS Timely submission of supplemental documents requested by MFDS, if any Management of promotional materials with out of date product information Support the regulatory activities in license management, if any.
-- Assist in SOP development and review.
Provide regulatory input to product lifecycle planning.
ESSENTIONAL KNOWLEDGE & SKILLS Sound knowledge of general medicine or pharmacy and clinical practice Knowledge of local regulatory requirements/guidelines and global standards Fluency in written and spoken English in addition to local language(s) Awareness and familiarity with industry principles of drug development and pharmacology Proficiency in Global and Local SOPs Knowledge of the Janssen Korea products Good interpersonal communication skills Ability to negotiate and communicate with internal and external customers QUALIFICATIONS Education.
a Bachelor or higher degree in pharmacy, or equivalent training as a healthcare provider Experiences.
previous experience on the pharmaceutical industry or medical environment is desired TRAINING REQUIREMENTS Johnson & Johnson requirements (AEPQC, IAPP, ILMW) Local SOPs (including SUMMIT Training) KEY WORKING RELATIONSHIPS Internal -- All departments of Janssen Korea, especially production, Q&C, logistics, marketing, PR, GCO, Market Access, Medical, etc.
Regional RA External -- Ministry of Food and Drug Safety Healthcare professionals [JD 확인 및 지원 방법] www.
areers.
nj.
om -> Requisition number W 검색 -> 해당 모집 공고 클릭 후, “Apply Now” [제출 서류] 영문 자유 양식의 이력서/ 경력기술서/ 자기소개서 [서류 마감일] 채용시 마감 [유의사항] 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.
서류 전형 합격자에 한하여 개별 통보합니다.
단, 회사 사정에 따라 지연 될 수 있습니다.
모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다.
www.
areers.
nj.
om Qualifications.