Manager, Regulatory Affairs

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.