Regulatory Affairs Consultant – Nonclinical Cell & Gene Therapy

Role Overview

• Organize, analyze, effectively and accurately communicate scientific data, methodologies, and conclusions in both written and verbal formats.
• Contribute to the preparation, review, and authoring of nonclinical regulatory documents, including IND, CTA, NDA, BLA, briefing packages, investigator brochures, and related submission materials.
• Support the development of nonclinical strategies that align with product-specific scientific considerations, regulatory expectations, and overall clinical development plans.
• Support nonclinical gap assessments and assist with the design, review, and interpretation of pharmacology, biodistribution, toxicology, immunogenicity, and safety studies.
• Review nonclinical study protocols, reports, and supporting data to ensure scientific quality, regulatory compliance, and consistency with development objectives.
• Participate in client-facing meetings and multidisciplinary project teams.
• Monitor and interpret evolving FDA, EMA, ICH, and other global regulatory guidance relevant to nonclinical development, particularly for advanced therapy products.
• Collaborate with internal subject matter experts and project teams to ensure timely delivery of high-quality consulting services.
• Support business development activities through technical input for proposals, client discussions, and scientific presentations, as appropriate.
• Independently execute assigned technical activities and deliverables within established frameworks.
• Apply existing regulatory guidance and scientific precedent to solve defined problems.
• Receive guidance on novel, highly complex, or strategically challenging development questions.
• May review limited portions of work produced by peers or junior staff.

Requirements

• Education: PhD, DVM, PharmD, MD, or equivalent advanced degree in Toxicology, Pharmacology, Immunology, Molecular Biology, Cell Biology, Biomedical Sciences, or a related discipline.
• Experience: 2–5 years of relevant experience in the biopharmaceutical, biotechnology, CRO, consulting, or regulatory environment.
• Fundamental understanding of nonclinical drug development, including pharmacology, toxicology, and regulatory submission processes.
• Strong scientific writing and communication skills.
• Ability to manage multiple assignments and work effectively in a collaborative, client-focused environment.
• Depth and breadth across multiple of the following: Experience supporting cell therapy, gene therapy, genome editing, viral vector, RNA-based, or other advanced therapeutic development programs.
• Familiarity with FDA, EMA, ICH, and global regulatory guidance applicable to biotechnology products and advanced therapies.
• Experience with nonclinical safety assessments, biodistribution studies, immunogenicity evaluations, and translational development strategies.
• Previous experience at a regulatory agency (e.g., FDA, EMA, MHRA) is a plus.
• Experience participating in regulatory interactions and health authority meetings is desirable.
• Scientific and critical thinking.
• Technical writing and data interpretation.
• Regulatory knowledge and compliance.
• Client relationship management.
• Communication and presentation skills.
• Project planning and organization.
• Team collaboration and adaptability.
• Ability to learn new therapeutic modalities and technologies quickly.