[Innovative Medicine] Regulatory Affairs Manager

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:
People Leader

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 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 dat...