RA高级总监VP

面议

北京市

刷新时间：2022-06-22

职位描述

Full Job Description
Company Description: Axter Therapeutics is an innovation-driven global biopharma company focused on the discovery, development and commercialization of novel and highly differentiated biologics for oncology and CNS diseases. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer and CNS diseases. Axter has offices in Beijing in China, and Maryland in the United States.

Position Summary: The Regulatory Project Manager (RPM), reporting to the VP of Clinical Development and Regulatory Affairs, will be responsible for establishing, assisting and maintaining a centralized document office in support of regulatory submissions for Axter. The RPM will be obtaining and maintaining licenses and applications in accordance with agreed regulatory team strategy and per country regulations. Actual position level will be decided and adjusted on the basis of qualifications, merit, and business development.

Essential Functions of the Job:
• Take ownership of systems, timelines, and documents in the centralized document office and continuously update processes to fit growing needs
• Assign documents to the appropriate partner/business vendor and monitor each document’s progress and its timeline through continuous communication; relay updates to regulatory affairs team/requestor of the documentation
• Provide routine progress reports concerning the ongoing document status at cross-functional meetings, including senior management
• Lead meetings with stakeholders to educate on current processes while receiving and utilizing feedback
• Help to ensure downstream functions such as regulatory operations, Technical Editing, and Quality Assurance are kept apprised of any changes to the agreed to timeline
• Proactively communicate to the line manager of any upcoming timeframes where additional support might be needed
• Be a business liaison for both China and US regulatory affairs including maintaining vendor contracts/licenses and invoices, purchase requests, purchase orders, etc.
• Manage legalization vendor timelines, expectations, and oversee all vendor communication
• Responsible for the ordering and tracking of specific regulatory documentation such as Legal documentation e.g., Letters of Authorization and Powers of Attorney. This responsibility includes ordering of Certificate of Pharmaceutical Products (CPPs), Free sale certificates, Signatures needed for declaration letters and any document deemed necessary to support regulatory applications
• Other duties as assigned to help develop more efficient ways of processing documents and activities
 
Qualifications:
• At least 3+ years of relevant industry or clinical research experience; familiarity with the Regulatory Affairs function
• Excellent written and oral communication skills in both Chinese and English
• Exceptional organizational skills, memory, and attention to detail
• Critical thinking and problem-solving abilities: Being able to anticipate problems and independently devise solutions before consulting line manager
• Ability to effectively prioritize and execute tasks in a high-pressure, fast-paced environment is crucial
• Independently motivated, requiring minimal supervision
• Excellent interpersonal skills; a team player
• Flexibility: Adept at managing shifting timelines, priorities, and has the ability to multitask
• Technical proficiency in Adobe Acrobat, Microsoft Outlook, Excel, Word, and PowerPoint; familiarity with Smartsheet, SAP, and electronic document management systems such as Veeva Vault
• Familiarity with regulatory documents
• Possess a high degree of personal responsibility
• Exhibits impeccable integrity and good judgement with sensitive information.
• Job Location: Beijing (current), may be transferred to the US site with the progress of the projects.
Education Required:
• Bachelor’s or higher degree in Project Management, Life Sciences or other related area required

其他要求

招聘人数：1人
职能类别：注册总监

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。