About this opportunity
Parexel lists this Remote Senior CMC Regulatory Lead - Biologics opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.