Regulatory Affairs Executive សំរាប់ Zuellig Pharma Ltd.
| សំរាប់ : | ជនជាតិខ្មែរ |
| ផ្នែក : | រដ្ឋបាល, ប្រតិបត្តិ/គ្រប់គ្រង, សុខភាពនិងឱសថ |
| ពេលធ្វើការ : | ពេញម៉ោង |
| ភេទ : | ប្រុស, ស្រី |
| ភាសា : | ខ្មែរ |
| តំបន់ : | ភ្នំពេញ |
| ចំនួន : | 1នាក់ |
| ឈប់ទទួលពាក្យ : | ថ្ងៃទី 26 ខែ ធ្នូ ឆ្នាំ2025 |
| ប្រាក់ខែ : |
តាមការចរចារ
|
| បទពិសោធន៍ : | យ៉ាងហោចណាស់ 3ឆ្នាំ |
| សញ្ញាបត្រ : | បរិញ្ញាបត្រ |
Zuellig Pharma (ZP) is one of the largest healthcare services groups in Asia and our purpose is to make healthcare more accessible.
For 100 years, we have been the trusted partner for healthcare companies looking to realize opportunities in Asian markets. With our deep-reaching infrastructure and sole focus on healthcare, we offer our clients unparalleled access to all healthcare channels across 13 countries in the region. Our focus is always about combining our market insight with a thorough understanding of your needs to deliver the best solution that connects you to patients. We believe delivering your products is only the first step to capturing the Asian markets. That is why we have continued to invest in developing innovative solutions that expand across Distribution, Clinical Reach, Sales & Marketing, Patient Centered Services, and Community Pharmacies.
Zuellig Pharma is the leading provider of distribution services to manufacturers in the life science industry in the Asia Pacific region. With operations in 13 countries or territories Zuellig Pharma has strong market positions, critical mass, broad geographic coverage and significant potential for continuing growth.
We are looking for the position below.
- Liaise between Ministry of Health and company to register products
- Ensure company’s compliance with government regulations governing license to operate
- Ensure to prepare complete-and-accurate dossiers for all product registration / renewal is submitted and approved within the set timeframe
- Ensure that all manufacturers of product registration/renewal are submitted and approved within the set timeframe
- Ensure that all Khmer PI of product to registration or updated are submitted and approved on time. And work with stakeholders end-to-end process until KH PI implemented.
- Prepare and update product artwork, when necessary, under your client’s responsibility, within the timeline of client or ZP SOP
- Ensure all variation and notification submitted to MOH on time (Within the timeline of client or ZP SOP) and approved within the set timeframe
- Once a marketing authorization (MA) or variation is obtained to update the regulatory status, RA tracker. To inform all department related functions such as marketing and scientific/medical information, PV and/or QA for submission date and approval date and keep evident.
- Accurate for hard filling and soft filling for document was submitted and approved from MOH (Included necessary communication with clients or other department).
- Work together with QA have all redressing instruction in eRWI, under your client’s responsibility.
- Coordinate with supply chain on build up stock in case of late renewal, under your client’s responsibility.
- Joining RA meeting with MOH or Client when necessary
- Prepare and update the monthly RA report sent to Head of RA & QA and clients (if requested on a monthly basis)
- Response and communicate to any queries of Client on the registration requirement timely
- Ensure you well prepare yearly for the forecast budget for RA activities per request by RA Head.
- Ensure you have a well-prepared check list for all products planning submission and approval by yearly. And send mail to inform your clients about all products submission plan.
- Response and communicate to any queries of Client on the registration requirement timely
- To submit the advertising submission in the best possible timing and in accordance with current local regulatory requirements, to follow up at very regular to ensure to receive the approval in a timely manner.
- Organize and/or coordinate contacts with the local Health Authority (particularly, Urgent communication with the Local Health Authority in coordination with headquarters, in case of Urgent Safety Restriction.
- Other Duties:
- Handle other tasks assigned by RA Head/RA Manager
- Attend trainings and meetings as required by the company
- Adhere to company policies
- Major Challenges (The major challenges the position faces in carrying out the job, how to overcome)
- Build professional relations with MOH
- Professional relations with all personnel and all other staff of the company
- Bachelor's Degree in medical Doctor/Pharmacist/Business Administration
- Almost in RA field at Local Pharmaceutical Manufacturing for 3 years
Interested candidates can submit CV with recent photo before the closing date through email address or contact details. Only shortlisted candidates will be notified. Salary and other benefit are very competitive and attractive compare to the market pay.
នៅពេលអ្នកដាក់ពាក្យសំរាប់ការងារនេះ ប្រសិនបើអាចសុំជួយប្រាប់ទៅកាន់ក្រុមហ៊ុនថា "អ្នកបានឃើញការងារនេះក្នុងគេហទំព័រ www.khmeronlinejobs.com".
អរគុណទុកជាមុន,
ពីក្រុមការងារ ខ្មែរអនឡាញចប
| ឈ្មោះក្រុមហ៊ុន : | Zuellig Pharma Ltd. |
| អុីម៉េល : | menen@zuelligpharma.com |
| អាស័យដ្ឋាន : | St. Lom, Boeung Salang Village, Sangkat Ruessei Kaev, Khan Russey Keo, Phnom Penh, Cambodia |
| គេហទំព័រ : |
http://www.zuelligpharma.com |
