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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.

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We are searching for the best talent for [Regulatory Affairs Manager]

The purpose of this position is to ensure the timely and compliant registration and approval of new products, including managing CMC variations, label updates, and clinical trial applications in accordance with regulatory requirements. It aims to facilitate effective communication and collaboration with regional and global regulatory authorities to support product lifecycle management. Ultimately, the role ensures that all regulatory activities are executed accurately to maintain product compliance and facilitate smooth market access.

[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• Management of promotional materials with out of date product information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.

[Requirements]

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(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.