Associate Director Regulatory CMC
ProClinical is advertising a vacancy for a Regulatory CMC Associate Director with a global biopharmaceutical company. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD) and respiratory fields, as well as actively participating in the fields of autoimmunity, neuroscience, and infection.
This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide. The Regulatory CMC Associate Director is responsible for the global CMC submission and approval of oncology biosimilars and post approval changes.
- Lead submission and approval of oncology biosimilars in US and ROW by 2020 based on EMA approval
- Lead health authority interactions along with technical experts to facilitate approval
- Post approval regulatory strategic planning, execution and interactions
The Regulatory CMC Associate Director possesses strategic leadership skills, understands regional (US or EU) and/or global regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of the oncology disease area is an important enabler to being able to influence cross-functional discussions with Product Development Teams (PDT) and relevant internal and external stakeholders.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.