Regulatory Affairs Consultant – Nonclinical Cell & Gene Therapy

Eliquent Life Sciences, Inc• US,

8d•$95,000 - $116,000•Remote

About The Position

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.

Requirements

PhD, DVM, PharmD, MD, or equivalent advanced degree in Toxicology, Pharmacology, Immunology, Molecular Biology, Cell Biology, Biomedical Sciences, or a related discipline.
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.

Nice To Haves

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

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.