北京招聘

Responsibilities:
? Plan and manage CMC regulatory activities related to assigned projects.
? Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects. 
? Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad. 
? Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents. 
? Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters. 
? Track and assess proposed manufacturing changes for impact for IND/IMPD/CTA/NDA/BLA filings and provide submission strategies.
? Develop and maintain current regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO’s as required.
Requirements:
? Experience and knowledge in preparation of INDs (desirable) and NDA/BLAs (desirable), and supportive amendments and supplements. Knowledge CTD/eCTD. Working knowledge of FDA, EMA and ICH regulatory guidance and regulations. 
? Understanding of CDE structure and function.
? Knowledge/experience with regulatory requirements for other regions also desirable. Prior experience on pharmaceutical development, manufacturing, QC, or QA preferred. Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle.
? Excellent oral and written communications skills are a must as are superior planning skills.
? Strong technical writing skills. Fluent spoken and written English is a must. 
? The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。