Senior Regulatory Affairs Lead - Remote, Global Submissions

Posted yesterday

pacelabsBrooklyn (NY)

Regulatory Affairs Specialists Biological Product (except Diagnostic) Manufacturing

SENIORITY

Manager

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About the role

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.

Before you apply

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Your profile is current

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Two examples you can talk through

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A number in mind

What you're on now and what would make you move. We negotiate better when we know both.

Your notice period

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Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.