- Develop submission strategies and plan study regulatory timeline- Management of FDA , EMA, MFDS and NMPA submission regards on going project- Management of FDA, EMA, MFDS and NMPA submission timeline- Assess regulatory aspe cts of study feasibility, support development team- Develop regulatory strategies and implementation plans in responsible territories for the preparation and submission of company pipelines and aligned with company goal- Manage Medicine, Vaccine, Medical dev ice, IVD and Health functional food regulatory process- Communicate with authorities/vendors/partner companies- Train and Manage of juniors

- Develop submission strategies and plan study regulatory timeline- Management of FDA submission regards on going project- Management of FDA submission timeline- Manage FDA IND (Form 1571) amendments (10 IND amendments were completed)- Successfully submitted and obtained ODD (Orphan Drug Designation) for B revaRex Pancreatic Cancer- Successfully submitted DSUR (Development Safety Update Report) for OvaRex Ovarian Cancer- Management of vendors- Manage authority’s regulations- Communicate with authorities/vendors/partner companies- Train and Manage of juniors

- Develop submission strategies and plan study regulatory timeline- Communicate with MFDS regards projects, queries, etc.- Manage global partner (RosVivo) regards Non-clinical and Pre-IND implementation- Discuss and implement strategies on miRNA regards Pre-IND submission- Search how to implement non-clinical studies in US and Korea- Participated INTERBIZ 2 times (2021 & 2022)- Manage FDA submission for non-clinical and Pre-IND submission- Communicate/manage venture capital company/investment company- Review venture capital company / investment company- Provide and manage juniors regards regulatory pathway / guideline- Support medical device department to submit class 2-3 medical devices to MFDS- Support medical device department on national assignments- Give guidance how to submit medical device to MFDS- Give guidance how to submit IND / NDA / BLA to MFDS and FDA- Review recent guideline from MFDS to provide regulatory intelligence/pathway to relevant team/person- Review guideline from FDA to provide regulatory intelligence/pathway to client, global partner and relevant team/person- Plan and review company’s upcoming strategies and goals- Review projects evaluation

- Develop submission strategies and plan study regulatory timeline- Track changes/amendments to legislation requirements related to clinical research and maintain the database of regulatory requirements- Assess regulatory aspects of study feasibility, support development team- Prepare clinical trial submission dossiers for MFDS - Submitted 9 INDs (Phase I, II and III) and received approvals for all of INDs- Communicate with regulatory authorities (MFDS), project teams and vendors on regulatory-related matters- Review translations of essential documents subject to submission- Track regulatory project documentation flow- Manage safety reporting to authorities- Deliver regulatory training to project team

- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.- Provide responses to regulatory agencies regarding product information or issues.- Develop regulatory strategies and implementation plans in responsible territories for the preparation and submission of new products, aligned with company goal.- In responsible territories, preparation and submission of regulatory agency applications, reports, or correspondence.- Manage MFDS submission for IND follow-up (amendment), IB amendment, Protocol amendment and CSR submission- Participate in the development or implementation of clinical trial protocols.- Maintain current knowledge of relevant regulations, ICH-GCP and company SOPs including proposed and final rules.- Train and assist the clinical staff in improving compliance with applicable regulatory requirements and guidelines- Communicate with MFDS and FDA agencies- Manage global partner companies

- Gather information / documentation from relevant departments to prepare FDA submission- Communicate/bridging role between Eutilex and global partner (CRO)- Prepare core documents for eCTD submission- Prepare and gather regulatory perspective information for FDA- Provide relevant information and/or core document to discuss current project to collaborate with partners- Communicate with global CRO to set up project timeline and managing projects

 Managing Products under Korea Regulation with compliance ways (Different Categories) Biologics- Closely work with Authority to discuss import process in compliance way- Work on LMO/GMO to be declared prior to import into Korea (Import declaration)- Reviewed more than 8,000 biologic (animal derived product, antibody, etc.) products to verify CoO (Country of Origin) and import requirement to safely imported into Korea- Have occasion meeting with authority to discuss format of import declaration as well as VC (Health Certificate)- Successfully negotiate with authority to accept propose to change format of health certificate with relevant thesis based on Korea regulation- Frequent communication with QIA (Quarantine Inspection Agency) to discuss most up dated guideline to eliminate obstacles in advance Electricity & Radio Wave (Equipment)- Analyzing E&E equipment (total 729 products) and clarify which products falls under KATS (Korean Agency Technology and Standard) and/or RRA (National Radio Research Agency)- Collaborate with Designated Test Institute to receive Certification or Exemption- Discuss with Business departments to prioritize products which need to receive certification for importation- Communicate with Global to discuss necessary require documents for E&E products to be certified in Korea Pharma/Food Materials- Collaborate with Pharma department to verify which products can be imported into Korea without hurdle under Korea regulation- Conduct labels for pharmaceutical raw material products- Review food material (Flavor and Fragrance) which can be imported into Korea or not- Conduct labels for food material products  MD/IVD- Review MD/IVD products whether it can be imported into Korea- Conduct labels for MD/IVD HS Code project- Collaborate with marketing team to prioritize products in compliance way of HS Code- Approximately 80,000 products classified by 4 priorities

- Project Manager for CT-P10 3.4 LTBFL (Managing 26 countries and 151 sites) project- Act as Regional Manager who maintain clinical trial will be ended within specific timeline- Managing clinical trials for specific projects (communicate with doctors) - Bridging Role between CRO (PPD) regards site pending issues as well as communicate with KOL (Key Opinion Leaders)- Acquired NOC (Notice of Compliance) from Health Canada. - Country Manager in Canada and Balkan region (6 countries including Serbia, Bosnia, Macedonia, Montenegro, Albania and Kosovo) who gathers regulatory intelligence and implement regulatory activities- Regulatory Activity has been conducted and still working throughout responsible countries- eCTD Submission to major pharmaceutical countries (EMA, Canada) as Project Manager- Manage eCTD Generation and eCTD Submission to EMA (3 times – as additional submission, sequence 0006 ~ 0008) as well as respond DL (Deficiency Letter) and Health Canada (25times – Implemented from Original submission to present submission) as well as respond Clarifax (similar to DL)- eCTD Expert (in Word and PDF as well as XML file) who collaborated with one of the most well-known company (CSC)- Dossier Filing (Canada, Australia, New Zealand, Serbia and Bosnia) for monoclonal antibody (mAb) Biosimilar products- ROW Dossier Building (Canada, Australia, New Zealand, Serbia and Bosnia), based on ICH CTD submitted to EMA and also redacted dossier building - eCTD In-house Project Vendor Selection (CSC)and Implementation in terms of software transit and internal personnel training in order to generate eCTD documents for dossier submission- CTD / eCTD Generation and Formatting in terms of generates bookmark, hyperlinks (internal / external) in MS word and PDF as well

- Introduced various medical device products to hospital staffs- Conducted workshops as a subject matter expert for hospital staffs- Relentlessly marketed Hanmi Medicare products to various hospitals and clinics

- Led 15 subordinate soldiers during training missions and war games- Responsible for morale, physical and mental well beings of junior soldiers- Successfully fulfilled compulsory national service according to South Korea’s constitution