Regulatory Affairs Specialist

Builds and submits the dossiers regulators read — IND, CTA, NDA.

Also known as: RA Specialist · Regulatory Submissions

What the role is

Regulatory Affairs professionals are the company's interface with FDA, EMA, MHRA and other authorities. They compile and submit INDs, CTAs, briefing books, annual reports and marketing applications, then negotiate questions back. Detail orientation and CTD/eCTD fluency are non-negotiable.

A typical day

• ▸Compile a Module 2.7 clinical summary
• ▸Track FDA Type C meeting briefing-book deliverables
• ▸Review a CMC change for regulatory impact
• ▸eCTD publishing QC for an annual report
• ▸Coordinate IRB amendments across 12 sites

Required skills

Certifications that matter

• RAC (Regulatory Affairs Certification)

Career ladder

Related career paths

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