Regularoty Affairs Head

面议

市辖区

刷新时间：2024-03-15

职位描述

We are looking for an experienced regulatory affairs expert in the pharmaceutical
industry with managerial experience. This candidate will directly report to the Chief
Medical Officer.

Main Responsibilities:
• Acting as a leader of Regulatory Affairs team;
• Responsible for registration strategy of all company projects in China and globally,
including pipeline products and BD projects;
• Responsible for planning and organizing of pre-IND or pre-NDA meetings, IND
or NDA submissions for pipeline products in China, and other worldwide countries;
• Involved in creating the R&D strategy and clinical development strategy of the
product portfolio;
• Responsible for interactions and communications with authorities in China and
worldwide (e.g., NMPA, FDA, EMA,PMDA etc.)；
• Familiar with drug regulatory policies and regulations, and be aware of any
important updates in China and globally, which supports the company’s decisionmaking;
• Responsible for regulatory knowledge management and training for the team;
• Other tasks assigned by the company.
Qualifications:
• Bachelor’s degree or above, majored in pharmacy, pharmacology, chemistry or the
biological sciences ;
• 15 years’ experience in Drug Development and Regulatory Affairs;
• Life-circle experience in biological industries;
• Able to effectively communicate internally and externally with proven persuasive,
assertive and negotiation skills, presentation skills (fluent English and Chinese).

主要职责:
•作为监管事务团队的领导;
•负责公司所有项目在中国和全球的注册策略，包括管道产品和BD项目;
•负责策划和组织在中国和世界其他国家的IND或NDA前会议，提交IND或NDA申请;
•参与制定产品组合的研发策略和临床开发策略;
•负责与中国和全球权威机构(如NMPA, FDA, EMA,PMDA等)的互动和沟通;
•熟悉药品监管政策和法规，并了解中国和全球的任何重要更新，以支持公司的决策;
•负责监管知识管理和团队培训;
•公司安排的其他工作。
资格:
本科及以上学历，药学、药理学、化学或生物科学相关专业;
•15年的药物开发和监管事务经验;
•生物行业全生命周期经验;
•能够有效地进行内部和外部沟通，具有良好的说服力，自信和谈判技巧，演讲技巧(流利的中英文)。

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。