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Regulatory Affairs Specialist Small Molecule

Jean Martin, IncUnited States🇺🇸United States

Why this role stands out

This hybrid role offers a fantastic opportunity to leverage your extensive experience in small molecule regulatory affairs and contribute to impactful clinical development programs at a reputable company. You'll thrive here if you possess strong IND, CTA, and NDA submission expertise, enjoy collaborating with clinical operations, and value regulatory documentation excellence, all while enjoying the flexibility of a hybrid work environment. Don't miss out on this chance to advance your career!

Quick overview

SeniorityMid Senior
Work modeHybrid
LocationUnited States
Clinical TrialsGoogle CloudVault

Job description

Job Title: Clinical Regulatory Affairs Specialist – Small Molecule
Location: Remote

We are seeking a Clinical Regulatory Affairs Specialist with 9+ years of experience supporting small molecule clinical development programs.
Key Requirements:
  • Strong experience in Clinical Regulatory Affairs
  • Hands-on experience with Veeva Vault TMF or similar.
  • Experience with IND, CTA, and NDA submissions
  • Knowledge of ICH-Google Cloud Platform, FDA, EMA, and global regulatory requirements
  • Experience supporting clinical trials and collaborating with Clinical Operations teams
  • Strong regulatory documentation and inspection readiness experience.

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