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 SoD until and including the MAA 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 810 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.

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.