Jobs in South Korea for English Speakers

Johnson & Johnson

Sr Regulatory Affairs Specialist

Johnson & Johnson is the world’s most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world competes in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world’s most pressing health issues.

[Summary]

  • 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.

[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  • Management of promotional materials with out of date product information.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.

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