[Janssen] Associate RA Manager (Contractor)

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. ???: Associate RA Manager

2. ???: ??(Janssen)

3. ???: ??? ???

4. ?? ??: Fixed-term

[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

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]

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 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: 10+ 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

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https://careers.jnj.com-> Requisition number “2406208593W” ?? -> ?? ?? ?? ?? ?, “Apply Now”

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www.careers.jnj.com