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:

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 Sr.

Regulatory Affairs Specialist:

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• Management of promotional materials with out of date product information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: 3~5 + of previous experience on 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

Legal Entity

Innovative Medicine(Formerly Janssen)

Job Type

Regular

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, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork