Johnson & Johnson Careers
Please enter a valid email.
Unfortunately, our network is not responding. Please try again later.
Your job alert was successfully created.
[Consumer] Regulatory Affairs Manager
Requisition ID: 1805648108W
Johnson & Johnson is the world's most
comprehensive and broadly based healthcare Company, touching the lives of
nearly a billion people every day. Our Family of Companies throughout the world
compete in consumer, pharmaceutical, and medical devices and diagnostics
markets and have the skills and resources to tackle the world's most pressing
1. 포지션: Regulatory Affairs Manager
2. 계열사:존슨앤드존슨 컨슈머 (Consumer)
3. 근무지: 서울시 용산구
Part A: Definition
- Manages and act the coordination, compilation and submission of new drug applications, abbreviated new drug applications and Investigational new drug applications to the regulatory agencies.
- External environmental influence on behalf of company’s position with up to date understanding of regulatory environment
Part B: Principal Responsibilities
- Coordinates and organize the activities concerned with the submission and approval products to government regulatory agencies.
- Provides guidance to project team members regarding regulatory compliance issues.
- Oversees or prepare & maintain the regulatory submissions and files and communication with agencies
- Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new drugs and regulatory support of marketed drugs and other products.
- Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
- Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Guides or provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables.
- Provides regulatory advice to project teams.
- Organizes and maintains reporting schedules for new drug application and investigational new drug applications
- Review and advice the regulatory review for artwork and advertisement materials
- Support or oversees the preparation of regulatory document for submission, and delivery to MFDS & receipt of approval letter from MFDS
- Oversee or review the promotional material based on local regulation
- Support for adverse event reporting
- Bachelor’s degrees or above
- Over 10 year experiences in Pharmaceutical company with OTC, OD/Cosmetic experience
- Knowledge in Chemistry, Chemical engineering or Pharmacy
- MS Office skills (Word, PPT, Excel) proficiency
- Good inter-personal relationship
- Proactive & positive & innovative mind
- Good communication & negotiation skills
- Strong analytical, problem solving and project management skills
- Good English communication (Writing & Verbal) ability
www.careers.jnj.com 접속 -> Position Number 1805648108W검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행
영문 자유 양식의 이력서/자기소개서
- 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.
- 온라인 접수시 “Create Your Account” 를 통해 개인 이메일 계정을 등록하신 후 온라인 지원 프로세스를 진행할 수 있습니다. Ex) G-mail/Naver/Daum 등
- 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다.
ohnson & Johnson Korea Sales & Distribution LLC (7227)