Regulatory Affairs Consultant

Job Summary

To support nonclinical development programs focused on cell and gene therapies, the full-time Regulatory Affairs Consultant will manage the design, evaluation, and regulatory documentation for submissions including IND, CTA, BLA, and NDA, while working remotely.

Key responsibilities

• Organize and communicate scientific data and methodologies in written and verbal formats
• Prepare, review, and author nonclinical regulatory documents and submission materials
• Support nonclinical strategies and conduct gap assessments related to pharmacology and toxicology studies

Required qualifications

• PhD, DVM, PharmD, MD, or equivalent advanced degree in a relevant scientific discipline
• 2-5 years of relevant experience in biopharmaceutical, biotechnology, or regulatory environments
• Fundamental understanding of nonclinical drug development and regulatory submission processes
• Strong scientific writing and communication skills
• Ability to manage multiple assignments in a collaborative, client-focused environment