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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Seoul, Korea, Republic of
Job Description:
**About Innovative Medicine **
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
**We are searching for the best talent for ** Associate RA Manager.
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 ACCOUNTABILITIES
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- Management of promotional materials with out of date product information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: 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
#LI-Hybrid
Legal Entity
Innovative Medicine
Job Type
Regular
Application Documents
Free-form resume AND cover letter is preferred (in Korean or English).
Application Deadline
Open until the position is filled.
Notes
- Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws.
- Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances.
- If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted.
- Submitted documents will not be returned and will be deleted upon request.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Business Writing, Coaching, Collaborating, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking