Director/Senior Director, Regulatory Affairs

面议

市辖区

刷新时间：2020-03-05

职位描述

Summary
This position reports to the VP, Global Regulatory Affairs. This individual provides local regulatory leadership at the US affiliate, supporting all clinical development programs assigned to that affiliate.

Education and Credentials
• Bachelors Degree in a relevant area is required. Advanced science degree is preferred.
• RAC certification or other equivalent is preferred.

Experience
• At least 6 years (Director) or 10 years (Senior Director) in diverse regulatory roles gained working for a pharmaceutical, biotechnology, or CRO company.
• Deep knowledge of US and EU regulations for biosimilars is preferred.
• Deep knowledge of regulations for drugs and biologics.
• Extensive familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing.
• Experience in various regulatory submissions and communication with regulatory agencies.
• Experience in working in multi-culture/multi-countries environment is preferred.


Skills
• Demonstrated ability to lead people in a positive manner.
• Demonstrated ability to manage multiple and diverse projects concurrently.
• Demonstrated ability to develop positive relationships and collaborations.
• Strong analytical skills; a strategic thinker, planner, and implementer.
• Ability to operate independently with minimal supervision.
• Excellent written and oral communication skills and a command of the English and Chineselanguage.
• Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).
• Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.

Responsibilities
• Oversees the coordination of submissions, and assists with the development of strategy for US and EU submission of new products.
• Contributes to the development of adequate regulatory strategies.
• Prepares and/or coordinates the preparation of submission documents.
• Provides guidance and support to product development teams on regulatory issues.
• Establishes standard operational procedures to achieve efficiency within regulatory affairs, including the interfacing with other departments.
• Keeps abreast of changes in the regulatory environment, identifies educational needs, sets up training sessions, and provides information on applicable regulatory topics to involved personnel across the organization.
• Provides input to the management team in establishing short and long-term business strategic plans and objectives.
• Creates and reviews abstracts and manuscripts created by internal or external sources.

其他要求

招聘人数：1人

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。