Regulatory Affairs Consultant

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