上海招聘

PREREQUISITES

BS/BA degree in Scientific Discipline (Masters or higher preferred) with 8-10 years in the pharmaceutical industry or in CRO, including 5-7 years CMC regulatory small molecule experience.

Responsibilities will include, but are not limited to, the following:

Responsible for the development of the CMC regulatory strategy for our submissions. These submissions include Health Authority Briefing Packages/IND regulatory filings. Prepare, coordinate and review CMC submission documents, registration dossiers, and responses to health authorities with other relevant line functions. Responsible for the regulatory evaluation of CMC change controls. Responsible for the management of CMC activities related to specific developmental or commercial compounds. Represent Regulatory CMC on CMC development/commercial and Regulatory Affairs teams.

In addition, take on leadership role in the CMC development/commercial teams. Interact with regulatory agencies and represent CMC at regulatory agency meetings.

Skills/Knowledge Required:
? Must have experience with CMC regulatory documents (e.g. MAA, CTD, supplements, responses), with specific emphasis on IND/IB in the USA and China; Experience in EOP2 and NDA CMC regulatory document preparation is a plus. 
? Experience in the development of CMC regulatory strategy for clinical candidates
? Knowledge of FDA, EMA and ICH guidelines.
? Interaction with regulatory agencies
? Have a solution-oriented approach to problem solving
? Expertise in either the drug discovery, preclinical development process
? Ability to work on complex projects and multi-discipline cross-functional teams
? Prior working experiences with CROs
? Experience with CMC regulations for compounds.

齐鲁制药集团总部位于山东省济南市，是中国大型综合性现代化制药企业，专业从事治疗肿瘤、心脑血管、抗感染、精神系统、神经系统、眼科疾病的制剂及其原料药的研制、生产与销售。

上海齐鲁创新药研发中心坐落于上海张江，是齐鲁创新药物研究、人才培养、国际合作交流的综合平台。负责齐鲁大小分子创新药研发的整体规划、创新药项目的研发、以及与海外创新药研发公司（美国西雅图、旧金山、波士顿研发中心）的协同。

行业荣誉：
中国企业集团竞争力500强
中国医药工业百强企业 第8位
中国制药工业百强企业 TOP10榜
中国化学制药工业企业综合实力百强 第2位
中国医药研发产品线***工业企业 第2位
中国医药十大最具影响力企业
十大最具成长力制药企业
中国医药三十年行业贡献奖
中国医药工业最具投资价值 TOP10榜
中国医药工业 50强
中国100家***医药工业企业
医药企业十优国际化先导企业

研发荣誉：
***企业技术中心
中国医药企业创新力二十强
中国医药研发产品线***工业企业
十大中国最具创新力医药企业
国内***研发产品线十佳工业企业
哺乳动物细胞高效表达国家工程实验室