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 Innovative Medicine and MedTech, 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
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 Regulatory Affairs Specialist
- 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 (including CCDS update) : 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 Management of promotional materials with out of date product information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 of regulatory activity in license management : Assist in SOP development and review.
- Provide regulatory input to product lifecycle planning.
Qualifications & Experience
- Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or a related field
- 0–3 years of experience in Regulatory Affairs within the pharmaceutical, biotech, or medical-related industry
- Basic understanding of MFDS regulations, drug registration processes, and product lifecycle management
- Experience with document review, preparation, or submission to regulatory authorities is a plus
- Familiarity with CMC, labeling regulations, and clinical trial application processes preferred (but not mandatory for junior level)
Skills & Competencies
- Strong attention to detail and ability to follow regulatory guidelines accurately
- Good communication skills to collaborate with cross-functional teams (e.g., Q&C, GCO, Medical, Marketing, Regional RA)
- Ability to manage multiple tasks and timelines simultaneously
- Basic analytical and problem‑solving skills
- Proficiency in MS Office (Word, Excel, PowerPoint)
- Ability to read and interpret scientific and regulatory documents
- Intermediate English communication skills (reading and writing mandatory; speaking is a plus)
#LI-Hybrid
Legal Entity
Innovative Medicine(Formerly Janssen)
Job Type
Fixed Term (1 year)
Application Documents
Free-form resume AND cover letter is required (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 Behavior, Business Writing, Collaborating, Communication, Confidentiality, Data Reporting, Data Savvy, Detail-Oriented, Execution Focus, Legal Support, Medicines and Device Development and Regulation, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments