Associate Director, CMC Regulatory Affairs

Full-time Other Management Occupations

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. 

We are looking for an Associate Director, CMC Regulatory Affairs (RA) who will work closely with our manufacturing and quality teams to develop and implement global CMC strategies for multiple biologics programs, from pre-clinical through Phase 3 studies. You will be a key member of project teams, shaping the CMC RA strategy and documentation for innovative new biologics and ensuring submissions are aligned with health authority requirements and delivered on time with quality.

How you might spend your days:

Serving as the primary CMC regulatory representative in project meetings and with regulatory agencies 

Preparing CMC regulatory submissions including briefing documents, IND ...