職位描述
The Healthcare Regulatory Affairs (RA) Manager ensures UPS Supply Chain Solutions remains in compliance with regulatory developments in the Asia Pacific Region (APAC).
SPECIFIC RESPONSIBILITES
1. Manages Regulatory Developments and Compliance
- Researches (e.g. regulatory agencies, monitors web sites and mailings etc) to maintain knowledge of regulatory changes and directions in APAC.
- Manages the submission of required reports and correspondence to agencies and ensures follow-up with agencies after inspections in Shanghai.
- Ensures requirements for licensure are researched and submit applications for licensure accurately and on time in Shanghai.
- Manages verification of customer (e.g. prescibers, distributors etc) to ensure regulatory requirements are met in Shanghai.
- Ensures guidance is provided to Business Development and Solutions to facilitate interpretation and compliance with licensing regulations in APAC.
2. Manages Healthcare Policy, Procedures, and Objectives Communication
- Consults with internal groups and manages investigations and problem solving regarding healthcare licensing issues to ensure healthcare compliance in APAC.
- Manages and develops standard operating procedures (SOPs) specific to regulatory requirements and provides training to ensure compliance in APAC.
- Review of policies, procedures and regulations with new and existing clients to determine specialized requirements and ensure compliance in APAC.
- Manages the relevant interactions with client RA departments in APAC.
- Participate in sales presentations and business reviews to contribute from a RA perspective as needed.
3. Manages and Assesses Risk
- Ensures client product types and service requirements (e.g. storage, prescriptions etc.) are identified so as to determine applicable regulations.
- Manages and conducts assessments of current UPS capabilities to determine its ability to meet client requirements and proposed solutions in APAC.
- Manages and establishes licensing and appropriate risk assessment procedures to minimize risk.
- Conducts consultations with Corporate Legal to determine compliance implications of pending business opportunities in APAC as needed.
- Interacts with BD, Implementations, Operations and Solutions on potential business opportunities from a RA perspective in APAC.
- Manages interactions with the Shanghai licensing agencies to ensure appropriate licensing verification and reporting.
4. Manages License Verification for Outbound Orders
- Manages license verification to ensure that customers receiving outbound shipments meet regulatory requirements in Shanghai.
5. Regulatory Responsibilities in APAC
- Be the Quality Responsible Person for the Shanghai facilities.
- Interface and interacts with the relevant regulatory authorities.
- Keep abreast of the latest regulatory knowledge in the various APAC countries.
- Perform the necessary regulatory research as needed by stakeholders.
REQUIREMENTS
- Shall have at least university education background in Pharmaceutical Science, medical devices or related subjects or similar majors.
- Advantageous to be a certified pharmacist or personnel with IVD laboratory experience for 3 years.
- Must be able to converse, write and read English and Mandarin.
- Advantageous to have more than 3 years experience in the quality management work experiences in the healthcare business (wholesale/distribution).
- Good experience in maintaining close relationship with various APAC regulatory authorities especially China FDA.
- Basic knowledge in healthcare regulation in APAC.
- Good communication and team work ability.
企業簡介
Let Your Career Take Off With the World39;s Largest Package Delivery Company and the Global Leader in Supply Chain Services
UPS最初作為一家信使公司于1907年在美國成立，現已發展成為一家擁有全球最受尊敬品牌之一、年營業額達數百億美元的公司。我們是世界上最大的快遞承運商與包裹遞送公司，也是提供專業運輸、物流、資本與電子商務服務的全球領導者。每天，我們在世界上 200 多個國家和地域有效管理著物流、資金流與信息流。
Founded in 1907 as a messenger company in the United States, UPS has grown into a multi-billion-dollar corporation with one of the most recognized and admired brands in the world. As the largest express carrier and package delivery company in the world, we are also a leading provider of specialized transportation, logistics, capital, and e-commerce services. Every day we manage the flow of goods, funds and information in more than 200 countries and territories worldwide.
當今世界上，沒有一家公司的包裹遞送量比得上UPS。我們每天遞送超過一千五百萬份包裹和文件。此外，我們是世界九大航空公司之一，每年進行超過五十萬件貨物的遠洋運輸，并處理超過五百萬次的美國海關登記手續。
No company in the world delivers more packages than UPS, moving more than 14 million packages and documents daily. In addition, UPS also operates one of the 9 largest airlines in the world, manages more than 500,000 ocean shipments annually and processes more than five million U.S. customs entry annually.
1988年，UPS開始在中國市場的業務。從那以后，我們在中國投入巨資來擴展遞送網絡，并提供更多的包裹遞送和供應鏈服務，以幫助中國企業找到更佳的方式來參與全球商業往來。
UPS commenced business in China in 1988, through a service agreement with Sinotrans. Since then, it has invested heavily in expanding its distribution network in China and providing more package delivery and supply chain services to reach its commitment to find innovative ways that will enable businesses in China to capitalize on global commerce.
UPS的重要優勢之一是我們的員工能夠朝著一個共同的目標而努力。盡管我們重視和不斷改進業務中所使用的工作方法、設備和程序，我們也一直認為忠誠、能干的員工是我們最寶貴的財產。我們相信每一位UPS員工以及他們所從事的工作都能為公司作出重要貢獻。基于這個認識，我們努力創造并維護一個良好的環境，使員工獲得工作滿足感。
The strength of UPS is its people, working together with a common purpose. Although methods, equipment, and procedures are important, and we constantly strive to improve them, our most valuable assets are loyal and capable people. We believe that all our people, and the jobs they perform, can make important contributions to our company. We maintain an environment that enables them to obtain personal satisfaction from their work.
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