Remote Senior CMC Regulatory Lead - Biologics

Parexel International seeks a Senior Regulatory Affairs Consultant – CMC Biologics for a remote international role. Lead regulatory strategy and submissions for biologics and small molecules across FDA, EMA, and Health Canada, coordinating with manufacturing, quality, and project management to ensure regulatory compliance.

You will develop CMC strategies, prepare submissions, and guide teams through GMP requirements, with opportunities to expand expertise in pharmaceutical development and