Regulatory Affairs Consultant – Nonclinical Cell & Gene Therapy

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ELIQUENT Life Sciences

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🤝 B2B

Biotechnology • Pharmaceuticals • B2B

ELIQUENT Life Sciences is a regulatory consulting firm that provides integrated regulatory, quality, and safety solutions to life sciences companies. They support pharmaceutical, biotechnology, medical device, and combination product sponsors across the product lifecycle — from early development and CMC strategy through regulatory submissions, pharmacovigilance, quality/compliance, remediation, and post‑approval support. ELIQUENT combines former regulators, industry leaders, and technical specialists to deliver hands‑on execution and strategic guidance for global market authorization and lifecycle management.

📋 Description

• 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.