We are looking for a self-motivated individual to join our regulatory affairs department to provide regulatory support for international clinical development of innovative cell therapies. This individual will have direct support from leadership and team members through training and continuous learning.
Location: MEDIPOST HQ located in Pangyo, Gyeonggi-do, South Korea (On-site)
Open Positions: Team Leader, Team Member(s)
Primary Responsibilities
- Regulatory affairs duties related to clinical development and marketing authorization of cell and gene therapies in the international market.
- Prepare and review document package (CTD) and other regulatory deliverables for international regulatory submissions
- Interaction with the applicable regulatory authorities for assigned projects
- Manage overseas (Japan) clinical trials – timeline/CRO/CMO/ partners management
- Support clinical development activities of foreign subsidiary companies
Basic Qualification
- Bachelor’s degree and 5+ years of experience in biology, life sciences or health-related field.
- Excellent verbal and written English and Korean communication skill
- Strong interpersonal, teamwork and organizational skills
Preferred Qualification
- Advanced degree (Master) in biology, life science, health-related field or regulatory affairs
- Experience in regulatory submissions for Advanced Therapy Medical Products (ATMPs) / Biologics
- GMP QA experience
- CRA experience
- Japanese language skill
Contact: Sophia Yang – sophia.yang@medipostamerica.com
About MEDIPOST
MEDIPOST is a Korean company founded in 2000 and became a public company in 2005, listed on KOSDAQ with 300+ current employees. MEDIPOST operates 2 overseas subsidiary companies in Tokyo, Japan and Gaithersburg MD, U.S.
MEDIPOST operates the largest private cord blood bank “CELLTREE®” in Korea with over 255,000 units of private cord blood units under storage. Each year, over 20,000 private cord blood units are collected and stored at CELLTREE®.
MEDIPOST’s research and development is focused on novel off-the-shelf, allogeneic cell therapeutics using human Umbilical Cord Blood-derived Mesenchymal Stromal Cells (hUCB-MSCs) with clinical-stage assets in the disease areas of osteoarthritis (OA), broncho-pulmonary dysplasia (BPD) and Alzheimer’s disease (AD).
MEDIPOST’s flagship product, CARTISTEM® (allogeneic Umbilical Cord Blood-derived MSCs + hyaluronic acid hydrogel composite) for knee osteoarthritis was approved in 2012 by Korea’s regulatory agency Ministry of Food and Drug Safety (MFDS) with Biologics License Application (BLA) label “Treatment of knee articular cartilage defects in patients with osteoarthritis (ICRS grade IV) as a result of degenerative disease or repeated trauma (without age limit)”. To date, over 21,000 patients have been treated on the market with an excellent long-term safety and efficacy profile. CARTISTEM® has also successfully completed the Phase I/II trial in the U.S. and the Phase III trial is planned to commence in 2023. CARTISTEM® is currently undergoing Phase III clinical trial in Japan, while BLA marketing-authorization is under review in Malaysia.
PNEUMOSTEM® (allogeneic Umbilical Cord Blood-derived MSCs) for the prevention of Bronchopulmonary Dysplasia (BPD) in premature infants, completed the first-in-human Phase I safety trial in Korea and the randomized, placebo-controlled Phase II clinical trial is ongoing in Korea. Phase I/II clinical trial in the U.S. has been completed confirming safety with positive efficacy signals. Longer term (3, 4 and 5 year) follow-up on premature infants born with high-risk of developing BPD who received PNEUMOSTEM® demonstrated significant benefit with regards to cognitive development compared to cohort of premature infants who received standard-care alone. PNEUMOSTEM® has received Orphan Drug Designation (ODD) and the Fast-Track Designation (FTD) by the US-FDA and ODD by the EMA.
MEDIPOST’s 2nd generation human Umbilical Cord Blood-derived Mesenchymal Stromal Cell (hUCB-MSC) pipeline code named SMUP-IA-01 is an off-the-shelf intra-articular injectable cell product for the patients with early to mid-stage knee osteoarthritis (OA). SMUP-IA-01 has completed dosing of all 12 subjects in the first-in-human Phase 1 clinical trial in Korea and the 12-months follow-up data demonstrated significant and sustained improvement in subjective pain and knee function assessments in all subjects, with longer-term follow-up planned. Phase 2 randomized controlled trial in Korea is currently ongoing.
SMUP platform is MEDIPOST’s proprietary, patent-protected cell selection and expansion technology using allogeneic umbilical cord blood-derived stem cells as a therapeutic modality. We are looking for qualified and experienced scientists to embark on the exciting journey of developing innovative cell and gene-modified cell therapy programs for unmet medical needs at MEDIPOST.
www.medi-post.com
KOSDAQ ticker: 078160
