Regulatory Affairs Consultant – Nonclinical Cell & Gene Therapy

Salary Range: $95,000.00 To $116,000.00 Annually Nonclinical Consultant – Cell & Gene Therapy Location: US Based - Remote Company Overview: ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information about ELIQUENT, please visit our website at eliquent.com. Position Overview: We are seeking a highly motivated Nonclinical Consultant to support nonclinical development programs with a focus on cell and gene therapies (CGT). The successful candidate will contribute to the design, evaluation, and regulatory documentation of nonclinical pharmacology and toxicology programs supporting IND, CTA, BLA, NDA, and other global regulatory submissions. This role is ideal for candidates with experience in nonclinical drug development and regulatory science who are looking to expand their expertise in advanced therapeutic modalities. Prior experience in cell and/or gene therapy development is preferred but not required. Essential Duties & Responsibilities 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 executes assigned technical activities and deliverables within established frameworks. Applies existing regulatory guidance and scientific precedent to solve defined problems. Receives guidance on novel, highly complex, or strategically challenging development questions. May review limited portions of work produced by peers or junior staff. Minimum Qualifications & Experience 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. Preferred Experience or Skills 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