南京招聘

About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.

Job Responsibilities:
-Development projects: local CMC RA China will provide the advice on the China CMC regulatory strategy and advice on CMC regulatory requirements (including review of critical CMC documents), during the development starting from Strat of development until and including the Marketing Authorisation Application in China.
-Lifecycle of Approved products: local CMC RA China will provide the input on China regulatory CMC strategy and advice on CMC regulatory requirements and topics (including review of critical CMC documents) for approved products.
-Further general tasks: Maintain, enhance and develop up to date CMC regulatory expertise for China

Requirements:
-Master’s or Doctoral Degree in Biochemistry, Biology, Biopharmaceuticals, Chemistry, or Pharmaceutics
-Work experience in CMC related Development (biological experience is preferred), and/or Pharmaceutical Production, Regulatory Affairs, and/or QA/QC of 8~10 years.
-At least 2 years work experience in the field of CMC RA. Track record of strategic and conceptional regulatory support of priority NCE/NBE development projects, product life cycle activities and general projects.
-Excellent understanding of chemical and pharmaceutical subjects as well as of GMP requirements. Biological technical experience is preferred.
-Substantial understanding of and experience in chemical/biological and pharmaceutical drug development, chemical/biological and pharmaceutical production, quality control and quality assurance
-Excellent English communication skills; fluent in reading/writing/speaking
-International working experience is preferred.
-With experience of regulatory affairs is preferred.

关于勃林格殷格翰
加入勃林格殷格翰，与我们一起携手并肩，共创未来。我们深信每一位员工的成长都将铸就公司的发展，每一位员工的努力也都将成就公司的美好明天。130余年来，研发驱动型制药公司勃林格殷格翰作为全球前20大制药企业之一，持续致力于人用药品、动物保健和生物制药合同生产三大业务领域，力争为人类和动物带来更多健康。加入勃林格殷格翰，将是您实现“创新展现价值”的绝佳机会！在工作中，您将通过与内外部伙伴的通力合作，站在知识迭代的最前沿；科研过程中，您将不断探索新型科学发现，切实提高全人类的生活质量；与此同时，您也将助力公司成为未来行业当之无愧的领导者。

我们的业务正处在持续高速发展之中，是中国业内发展最快的公司之一。我们诚邀您加入勃林格殷格翰，共同携手向前，成为实现2025愿景的一份子。

作为业内的领导企业，热情、创新和独立是驱动我们不懈前行的动力，我们为每一位努力热忱、恪尽职守的员工提供成长机会，实现其个人价值。作为连续八年通过“中国杰出雇主”认证的企业，我们通过提供高质量的职业发展规划、参与或领导国际项目的机会，为每一位员工的成功之路夯实基础。
 让我们彼此成就，引领未来！

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行为准则
-责任心：即使情况不明朗，我们总是在自己的决策和行为中展现主人翁精神
-敏锐度：面对内外部变化时，我们以开放的心态快速应对
-内部企业家精神：我们与客户携手构筑创新理念，以应对瞬息万变的市场

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