[Janssen] Sr. RA Specialist

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/ .

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Position: Sr.

RA Specialist
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Sector: Janssen ( 한국얀센 )
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Location: Yongsan-gu, Seoul
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Work Type: Regular

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

[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 Accountability]

- New product registration


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+ 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


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+ Reviewing the dossier and submitting to MFDS in line with Q&C
+ Timely submission of supplemental documents requested by MFDS, if any

- Label updates


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+ 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


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+ 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+ Management of promotional materials with out of date product information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.


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+ Assist in SOP development and review.
+ Provide regulatory input to product lifecycle planning.

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's or higher degree in pharmacy, or equivalent training as a healthcare provid...