Director of regulatory affairs
西比曼生物科技（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资（欧美）
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-07-15
- 工作地点：上海-徐汇区
- 招聘人数：1人
- 工作经验：8-9年经验
- 学历要求：硕士
- 语言要求：英语 熟练
- 职位月薪：2-5万/月
- 职位类别：药品注册
职位描述
职位描述：
Job Summary: Director of regulatory affairs
Job Objective:
- To develop and implement the regulatory strategy and be responsible, to prepare and supervise all relevant documents for regulatory authorities for IND and clinical studies. This will include interactions with authorities and other key players in the regulatory environment.
- Role:
? Define the regulatory development strategy for the company’s products
? Develop local and national regulatory submission strategies
? Conduct regulatory reviews of technical summaries, clinical study reports, and administrative documents for regulatory filings to support clinical trials (Clinical trial Applications, Investigational New Drugs or equivalents) in collaboration with functional experts.
? Advise on regulatory aspects of protocols and clinical trials.
? Ensure timely submission and appropriate follow-up
? Interact directly with regulatory agencies/competent authorities and/or other regulatory or functional experts and represent the company with health authorities
The position is based in China and requires domestic travels
Reporting: COO
Job Requirements:
Requirements:
- Pharmacist and/or Master or PhD degree in a relevant field with at least 5-year regulatory affairs experience in pharmaceutical and/or biotechnology industry in China.
- Experience and understanding of Drug development as well as understanding of biology relevant to therapeutic area.
- The candidate must be a team player, self-starter, strategic thinker, persistent, tactful, and persuasive.
- Excellent verbal and written communication skills: accustomed to communication with authorities and ability to convince through knowledge and interpersonal skills
- Oral and written English is essential
Preferred:
- Regulatory biological CMC experience
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Job Summary: Director of regulatory affairs
Job Objective:
- To develop and implement the regulatory strategy and be responsible, to prepare and supervise all relevant documents for regulatory authorities for IND and clinical studies. This will include interactions with authorities and other key players in the regulatory environment.
- Role:
? Define the regulatory development strategy for the company’s products
? Develop local and national regulatory submission strategies
? Conduct regulatory reviews of technical summaries, clinical study reports, and administrative documents for regulatory filings to support clinical trials (Clinical trial Applications, Investigational New Drugs or equivalents) in collaboration with functional experts.
? Advise on regulatory aspects of protocols and clinical trials.
? Ensure timely submission and appropriate follow-up
? Interact directly with regulatory agencies/competent authorities and/or other regulatory or functional experts and represent the company with health authorities
The position is based in China and requires domestic travels
Reporting: COO
Job Requirements:
Requirements:
- Pharmacist and/or Master or PhD degree in a relevant field with at least 5-year regulatory affairs experience in pharmaceutical and/or biotechnology industry in China.
- Experience and understanding of Drug development as well as understanding of biology relevant to therapeutic area.
- The candidate must be a team player, self-starter, strategic thinker, persistent, tactful, and persuasive.
- Excellent verbal and written communication skills: accustomed to communication with authorities and ability to convince through knowledge and interpersonal skills
- Oral and written English is essential
Preferred:
- Regulatory biological CMC experience
职能类别： 药品注册
公司介绍
西比曼生物科技是一个在美国特拉华州注册， 纳斯达克股票交易所上市，以中国市场为重心
的细胞治疗公司。公司主要从事开发癌症免疫疗法和退行性疾病干细胞疗法。CBMG汇集世界创新技术和行业领先科学家，为重症患者研发安全的治疗方法。 CBMG汇集世界创新技术和行业领先科学家，为重症患者研发安全的治疗方法。
公司总部坐落于上海张江法拉第路85号3号楼， 拥有扩张到70,000平方英尺（6503平方米）的达到国际标准的GMP厂房. 和美国通用电气公司中国分部建立了战略合作伙伴关系。公司拥有雄厚的管理团队，完善的临床科研技术力量配备，拥有一大批顶尖医学专家及技术科研人员。
癌症对于全球的公共卫生和卫生系统偿付能力都是一个重大威胁。目前这些疾病的治疗需求尚未完全得到满足。CBMG相信免疫细胞疗法有望以富有成效的方式减轻因这些慢性和退行性疾病而产生的医疗负担。CBMG正在开发用于再生医学的成体干细胞。CBMG已经完成用于治疗膝骨关节炎（KOA）的Rejoin？自体脂肪间充质祖细胞（haMPC）的中国IIb期试验，以及用于治疗KOA的 Allojoin? 异体人源脂肪间充质祖细胞 （CBMG的“现货”haMPC）的中国I期试验。
公司网址：***********************
的细胞治疗公司。公司主要从事开发癌症免疫疗法和退行性疾病干细胞疗法。CBMG汇集世界创新技术和行业领先科学家，为重症患者研发安全的治疗方法。 CBMG汇集世界创新技术和行业领先科学家，为重症患者研发安全的治疗方法。
公司总部坐落于上海张江法拉第路85号3号楼， 拥有扩张到70,000平方英尺（6503平方米）的达到国际标准的GMP厂房. 和美国通用电气公司中国分部建立了战略合作伙伴关系。公司拥有雄厚的管理团队，完善的临床科研技术力量配备，拥有一大批顶尖医学专家及技术科研人员。
癌症对于全球的公共卫生和卫生系统偿付能力都是一个重大威胁。目前这些疾病的治疗需求尚未完全得到满足。CBMG相信免疫细胞疗法有望以富有成效的方式减轻因这些慢性和退行性疾病而产生的医疗负担。CBMG正在开发用于再生医学的成体干细胞。CBMG已经完成用于治疗膝骨关节炎（KOA）的Rejoin？自体脂肪间充质祖细胞（haMPC）的中国IIb期试验，以及用于治疗KOA的 Allojoin? 异体人源脂肪间充质祖细胞 （CBMG的“现货”haMPC）的中国I期试验。
公司网址：***********************