핵심 정보
- 경력
- 경력 5년 ↑
- 학력
- 대졸(4년제) 이상
- 근무형태
- 정규직 수습기간 3개월
- 우대사항
-
- 외국어 능력영어능통자
- 활동/경험해당직무 근무경험
- 급여
- 면접 후 결정
- 근무지역
- 서울 용산구
본 채용정보는 마감되었습니다.
(주)한국얀센에서 채용공고가 시작되면 이메일로 알려드립니다.
상세요강
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.jnj.com/ .
DE&I Statement
For more than 130 years, diversity, equity &
inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson
and woven into how we do business every day. Rooted in Our Credo, the values of
DEI fuel our pursuit to create a healthier, more equitable world. Our diverse
workforce and culture of belonging accelerate innovation to solve the world’s
most pressing healthcare challenges.
We know that the success of our business – and our
ability to deliver meaningful solutions – depends on how well we understand and
meet the diverse needs of the communities we serve. Which is why we foster a
culture of inclusion and belonging where all perspectives, abilities and
experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
1. 포지션: Associate
Regulatory Affairs Manager
2. 계열사: 얀센 (Janssen)
3. 근무지: 서울시
용산구
4. 근무 형태: Regular
[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
[Main
responsibilities]
- 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 ma support the regulatory activities in license management, if
any.
Trials 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
Requirement
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: 5~7+ years of previous experience on
regulatory affairs 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 ]
https://careers.jnj.com -> Requisition
number “2406194779W”검색 -> 해당 모집 공고 클릭 후, “Apply Now”
[ 제출 서류 ]
영문 자유 양식의 이력서/경력기술서/자기소개서
[ 서류 마감일 ]
채용시 마감
[ 유의사항 ]
- 국가보훈 대상자
및 장애인은 관련
서류 제출
시 관계 법령에
의거하여 우대합니다.
- 서류 전형
합격자에 한하여
개별 통보합니다. 단, 회사
사정에 따라
지연될 수
있습니다.
- 입사 지원
서류에 허위
사실이 발견될
경우, 채용
확정 이후라도 채용이 취소될
수 있으며 향후
채용이 제한됩니다.
- 제출된 서류는
반환되지 않으며, 별도 요청
시 삭제합니다.
www.careers.jnj.com
기업정보
이 기업의 다른 공고 (3건)
이어보는 Ai매치 채용정보
사람인 인공지능 기술 기반으로 맞춤 공고를 추천해드리는 사람인의 채용정보제공 서비스입니다.
사람인 인공지능 기술 기반으로 맞춤 공고를 추천해드리는 사람인의 채용정보제공 서비스입니다.