Job Information
J&J Family of Companies [Janssen] Sr. RA Specialist in Seoul, South Korea
[Janssen] Sr. RA Specialist - 2406212767W
Description
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/ .
Position: Sr. RA Specialist
Sector: Janssen ()
Location: Yongsan-gu, Seoul
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Management of promotional materials with out of date product information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's or higher degree in pharmacy, or equivalent training as a healthcare provider
Experiences: more than 5 years of experience in 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 * * * * ]
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Qualifications
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Primary Location Asia Pacific-South Korea-Seoul-Yongsan-gu
Organization Janssen Korea, Ltd. (7220)
Job Function Regulatory Affairs
Req ID: 2406212767W
J&J Family of Companies
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