[Innovative Medicine] Senior Regulatory Specialist

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
Purpose:

To register products in a timely manner in support of business growth and to maintain full complice of products with regulatory requirements.


* 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Management of promotional materials with out-of-date product information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.

ESSENTIAL 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 pharmacolog...