Experience

Gencurix, Inc.

• South Korea
• Medical and Diagnostic Laboratories
• 1 - 100 Employee

• RA Specialist

  • Mar 2021 - Present

  - New product registration (Oncology) · Communicating with related departments to compile 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 R&D · Timely submission of supplemental documents requested by MFDS, if any - Label updates (including CCDS update) · Reviewing the documents and submitting to MFDS · Timely notification of label changes in accordance with appropriate SOP - Support the regulatory activities in license management · Assist in SOP development and review. · Provide regulatory input to product lifecycle plan using the weekly newsletter. · Coordinates regulatory activities between divisions · Lead development, implementation, and maintenance of GMP Quality Systems Show less



Ferring Pharmaceuticals

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• RA/QA assistant

  • Jul 2019 - Dec 2020

  - New product registration (Fertility) · 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 (including CCDS update) · Reviewing the documents forwarded from regional RA and submitting to MFDS · Timely notification of label changes in accordance with appropriate SOP · Updates the assigned Local Product Documents in consistent with the local regulations and CCDS update and ensure timely update notifications for the related systems - Support the regulatory activities in license management · Support Product license renewal with quality documents required per the regulation · Assist in SOP development and review. · Provide regulatory input to product lifecycle planning using the weekly newsletter. · Assist preparation of Transaction Agreement (Quality and Pharmacovigilance Agreement) · Aid voluntary recall process. Show less