杭州 [切换城市] 杭州招聘杭州生物/制药/医疗器械招聘杭州生物工程/生物制药招聘

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



公司介绍

上海药明生物技术有限公司诚聘

联系方式

  • Email:Biologics@wuxiapptec.com
  • 公司地址:荷丹路240号科创中心
  • 电话:13482827135