CMC Advisor

Department: CMRQ (Clinical, Medical, Regulatory and Quality)

Location: Beijing

The Position

•    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

Qualifications

•    Relevant graduate level degree, e.g. Pharmacy, Pharmacology, Biology;
•    Fluency in both written & spoken English;
•    Min 6+ years' experience in regulatory CMC with excellent regulatory CMC related knowledge (regulations, guidelines, intelligence) and experience in CMC of biological and biotechnological products;

•    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.
 

About the department
In CMRQ, we commit to bringing our products to Chinese market with the fastest speed and top quality, and applying the most scientific way to communicate our products' benefits to our customers. We have 6 team in CMRQ aming to portfolio evaluation and overall strategy; New product approval, Licence maintenance, Product localization; Clinical evidence trial operation Phase (I-IV, NIS); Multiple stakeholders' engagement (HA/KOLs/investigators) and Medical evidence generation/communication.

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.