Regulatory Affairs Consultant

Our On-Demand Talent Solutions team is partnering with an innovative early-stage biotechnology company to identify a Regulatory Affairs Consultant to support an upcoming IND submission. The ideal candidate has extensive FDA regulatory experience, a proven track record supporting IND submissions, and thrives in a collaborative, fast-paced startup environment. Summary This consultant will provide both strategic regulatory leadership and hands‑on execution, partnering closely with cross‑functional teams to develop and implement regulatory strategy, prepare and review IND submission documents, and drive overall IND readiness. Responsibilities Develop and execute regulatory strategies to support an upcoming IND submission. Lead the preparation, review, and compilation of IND submission documents, ensuring compliance with FDA regulations and applicable guidance. Provide strategic regulatory guidance while remaining actively involved in document authoring, review, and submission activities. Partner cross-functionally with nonclinical, CMC, clinical, quality, and external vendors to ensure regulatory readiness and alignment across development programs. Identify regulatory risks, develop mitigation strategies, and provide recommendations to support program advancement. Support FDA interactions, including meeting preparation, briefing documents, information requests, and regulatory correspondence. Stay current on evolving FDA regulations, guidance documents, and industry best practices relevant to early-stage product development. Qualifications Bachelor's degree in Life Sciences or a related field required; advanced degree (MS, PhD, PharmD, or equivalent) preferred. 10+ years of regulatory affairs experience within the biotechnology or pharmaceutical industry. Demonstrated success developing regulatory strategy and leading IND submissions to the FDA. Strong knowledge of FDA regulations, IND requirements, and drug development processes. #J-18808-Ljbffr