Opportunity Details

The Director will collaborate cross-functionally with internal teams to ensure alignment of CMC regulatory strategies with overall development plans and corporate objectives. They will stay current on regulatory guidelines and requirements, providing expertise and guidance to the client contact for CMC development teams. The Director will also lead regulatory intelligence activities, monitoring changes in regulations and guidelines that may impact CMC development programs.

The ideal candidate will have a strong background in Regulatory Affairs CMC, with experience leading regulatory strategies and submissions for pharmaceutical products. They will have a deep understanding of global regulatory requirements and a track record of successful interactions with Health Authorities. The Director must be a strategic thinker, able to identify opportunities for acceleration and navigate complex regulatory challenges to drive successful outcomes for the client.