Regulatory Affairs Consultant – Nonclinical Cell & Gene Therapy

This is a fully remote position, open to applicants in United States.

📋 Description

• Organize, analyze, and effectively communicate scientific data, methodologies, and conclusions through both written and verbal channels.

• Assist in the preparation, review, and authorship of nonclinical regulatory documents, such as IND, CTA, NDA, BLA, briefing packages, investigator brochures, and other related submission materials.

• Aid in the development of nonclinical strategies that are in line with product-specific scientific considerations, regulatory expectations, and overall clinical development plans.

• Support nonclinical gap assessments and contribute to the design, review, and interpretation of pharmacology, biodistribution, toxicology, immunogenicity, and safety studies.

• Evaluate nonclinical study protocols, reports, and supporting data to ensure scientific integrity, regulatory compliance, and alignment with development objectives.

• Engage in client-facing meetings and collaborate within multidisciplinary project teams.

• Monitor and interpret the evolving FDA, EMA, ICH, and other global regulatory guidance pertinent to nonclinical development, especially for advanced therapy products.

• Work alongside internal subject matter experts and project teams to guarantee the timely delivery of high-quality consulting services.

• Contribute to business development efforts by providing technical input for proposals, client discussions, and scientific presentations when appropriate.

• Independently carry out assigned technical tasks and deliverables within defined frameworks.

• Utilize existing regulatory guidance and scientific precedents to address specified challenges.

• Receive guidance on novel, highly complex, or strategically significant development inquiries.

• May review limited sections of work generated by peers or junior staff.

⛳️ Requirements

• Education: PhD, DVM, PharmD, MD, or an equivalent advanced degree in Toxicology, Pharmacology, Immunology, Molecular Biology, Cell Biology, Biomedical Sciences, or a related field.

• Experience: 2–5 years of relevant experience in the biopharmaceutical, biotechnology, CRO, consulting, or regulatory sectors.

• Fundamental knowledge of nonclinical drug development, including pharmacology, toxicology, and regulatory submission processes.

• Excellent scientific writing and communication abilities.

• Capacity to manage multiple projects and work efficiently in a collaborative, client-centric environment.

• Depth and breadth of experience in several of the following areas: 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 relevant to biotechnology products and advanced therapies.

• Experience in nonclinical safety assessments, biodistribution studies, immunogenicity evaluations, and translational development strategies.

• Prior experience at a regulatory agency (e.g., FDA, EMA, MHRA) is advantageous.

• Experience in regulatory interactions and health authority meetings is desirable.

• Strong scientific and critical thinking capabilities.

• Proficient in technical writing and data interpretation.

• Knowledge of regulatory compliance.

• Skills in client relationship management.

• Effective communication and presentation abilities.

• Competence in project planning and organization.

• Team collaboration and adaptability.

• Ability to quickly learn new therapeutic modalities and technologies.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional growth and development.

• A collaborative and innovative work environment.

• Flexible work arrangements to support work-life balance.