About this opportunity
Pacelabs lists this Senior Regulatory Affairs Lead - Remote, Global Submissions opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Pace is seeking a Senior Regulatory Affairs Specialist (Remote) to lead global CMC regulatory strategies. You will author and compile CMC sections for INDs, IMPDs, CTAs, amendments, and reports, and draft Module 2/3 documents with precision.
Ideal candidates bring 10+ years in CMC/regulatory affairs, strong documentation skills, and experience interfacing with FDA/EMA/PMDA. Includes a comprehensive benefits program for full-time staff.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.