[한국얀센] Associate 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 pharmaceutical, medical devices and diagnostics markets, 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/ .

DE&I Statement

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

1. 포지션: Associate Regulatory Affairs Manager

2. 계열사: 얀센 (Janssen)

3. 근무지: 서울시 용산구

4. 근무 형태: Regular

[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  

[Main responsibilities]

- 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 ma support the regulatory activities in license management, if any.

   Trials 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

Requirement

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

[JD  확인   및   지원   방법 ]
https://careers.jnj.com -> Requisition number “2406194779W”검색 -> 해당 모집 공고 클릭 후, “Apply Now”

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