CMC Advisor

Key responsibilities 重要职责

• Regulatory Planning and CMC Strategy Development
• Submissions and Approvals for CMC Issues Relevant to New Products, License Renewals, Variations, Annual reports, Deregistrations, etc.
• Regulatory Policy and Influence
• Regulatory Compliance and System
• Cross Function/Department Supporting
• Budget Planning and Control

Knowledge, skills and experience 知识、技能和经验

• Good understanding of Chinese regulatory CMC policies and requirements, and familiarity with global regulatory CMC practices.
• Strong teamwork and experience sharing abilities.
• Ability to handle multiple tasks simultaneously.
• Good oral and written communication and interpersonal skills.
• Ability to handle conflicts: initiative and negotiation skills.
• Effective communication skills with internal customers.
• Strong analytical skills: accuracy and reliability.
• Creative thinking and problem-solving abilities.
• Relevant graduate level degree, e.g. Pharmacy, Pharmacology, Biology.
• Fluency in both written & spoken English.
• Min 6+ years’ experience in regulatory CMC.
• Excellent regulatory CMC related knowledge (regulations, guidelines, intelligence) and experience in CMC of biological and biotechnological products

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.