JANSSEN] RA MANAGER (CONTRACTOR)

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.
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om/.
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 RA Manager 2.
계열사.
얀센(Janssen) 3.
근무지.
서울시 용산구 4.
근무 형태.
Fixed-term [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 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] ESSENTIAL 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.
10+ 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.
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