Director, Regulatory Affairs CMC
上海药明生物技术有限公司
- 公司性质:民营公司
- 公司行业:计算机软件
职位信息
- 发布日期:2019-05-07
- 工作地点:上海-浦东新区
- 招聘人数:若干人
- 工作经验:无工作经验
- 学历要求:招若干人
- 语言要求:不限
- 职位月薪:3-4.5千/月
- 职位类别:生物工程/生物制药
职位描述
MAJOR RESPONSIBILITIES
Provide regulatory CMC guidance to the project teams to ensure development activities are compliant with relevant guidelines and governmental regulations
Supervisor the preparation of global CMC regulatory submissions namely INDs/BLAs applications including scientific and technical review for accuracy, soundness and regulatory appropriateness
Represents WuXi Biologics in interaction and communication with Regulatory Agencies and clients’ RA CMC representatives
Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development
The candidate is expected to maintain up-to-date knowledge and expertise of relevant ICH guidelines, CFDA, FDA, and EMA regulations
Responsible for establishing and maintaining internal filing template and ensure submission quality and consistency
QUALIFICATIONS REQUIREMENTS
The candidate must demonstrate solid broad working knowledge of biologics development processes and deep expertise in CMC
Thorough understanding of FDA and EMA regulatory requirements and GMP regulation is required
Excellent verbal and written communication skills
Demonstrated leadership success in management of cross-team and regulatory activities
Creative problem solving and strategizing abilities
The candidate must be detail oriented with strong project management, problem-solving, negotiating, interpersonal, and communication skills (both written and oral)
Minimum BS degree in a scientific discipline. Advanced degree and RAC certification are pluses
BS degree with 15 years experience
MS degree with 12 years experience
PhD degree with 8 years experience
职能类别: 生物工程/生物制药
公司介绍
联系方式
- Email:Biologics@wuxiapptec.com
- 公司地址:荷丹路240号科创中心
- 电话:13482827135