Regulatory Affairs Consultant – Nonclinical Cell & Gene Therapy

ELIQUENT Life Sciences

Nonclinical Consultant supporting nonclinical development programs focused on cell and gene therapies. Collaborating on regulatory documentation and scientific strategies at ELIQUENT Life Sciences.

Posted 7/14/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-Level💰 $95,000 - $116,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in nonclinical drug development, including pharmacology, toxicology, and regulatory submission processes, while effectively communicating scientific data and collaborating with multidisciplinary teams. Proficient in managing multiple assignments and providing high-quality consulting services in a client-focused environment.

Highest-signal resume keywords

PhD, DVM, PharmD, MDNonclinical Drug DevelopmentRegulatory Submission ProcessesScientific Writing and CommunicationClient Relationship Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacologyToxicologyImmunologyMolecular BiologyCell BiologyTechnical WritingData InterpretationRegulatory KnowledgeNonclinical Safety AssessmentsBiodistribution Studies

Soft Skills

Communication SkillsTeam CollaborationProject PlanningAdaptabilityCritical Thinking

Industry Keywords

FDAEMAICHBiotechnologyAdvanced TherapiesCROConsultingRegulatory ComplianceHealth Authority MeetingsCell Therapy

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account ELIQUENT Life Sciences Website LinkedIn All 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. Regulatory Affairs Consultant – Nonclinical Cell & Gene Therapy Job not on LinkedIn 🔥 14 minutes ago 🇺🇸 United States – Remote 💵 $95k - $116k / year ⏰ Full Time 🟢 Junior 🟡 Mid-level 😶‍🌫️ Therapist Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 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. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Licensed Physical Therapist, Care Navigator 🔥 7 hours ago Net Health 501 - 1000 ☁️ SaaS 🤝 B2B 🤖 Artificial Intelligence Website LinkedIn All Job Openings Care Navigator role at Net Health, providing remote patient support through therapy. Emphasizing patient success and collaborative relationships in a high-growth healthcare startup. 🇺🇸 United States – Remote 💵 $28 - $36 / hour ⏰ Full Time 🟢 Junior 🟡 Mid-level 😶‍🌫️ Therapist 🦅 H1B Visa Sponsor Business Development Associate – Cell & Gene Therapy 🔥 12 hours ago McKesson 10,000+ employees ⚕️ Healthcare Insurance 💊 Pharmaceuticals 🧬 Biotechnology Website LinkedIn All Job Openings Business Development Associate supporting early-stage business development activities for cell and gene therapy. Engaging with prospective customers, opportunity qualification, and relationship development across U.S. and Canada. 🇺🇸 United States – Remote 💵 $77.6k - $129.4k / year ⏰ Full Time 🟢 Junior 🟡 Mid-level 😶‍🌫️ Therapist 🦅 H1B Visa Sponsor Licensed Mental Health Therapist – LMFT, LCSW, LPCC, PsyD 🔥 12 hours ago Cyti Psychological 201 - 500 ⚕️ Healthcare Insurance 🧘 Wellness ☁️ SaaS Website LinkedIn All Job Openings Licensed Mental Health Therapist providing virtual therapy sessions via telehealth platform for California clients while residing in Arizona. Focus on flexible schedules and client-centered care. 🇺🇸 United States – Remote 💵 $80 - $100 / hour ⏰ Full Time 🟡 Mid-level 🟠 Senior 😶‍🌫️ Therapist Associate Mental Health Therapist, ACSW, AMFT 🔥 13 hours ago Ascend Healthcare 11 - 50 ⚕️ Healthcare Insurance 🧘 Wellness 🤝 Non-profit Website LinkedIn All Job Openings Licensed Associate Clinical Social Worker providing telemedicine therapy for mental health in California. Focused on patient care and evidence-based practice in a remote-first environment. 🇺🇸 United States – Remote 💵 $70k - $80k / year ⏰ Full Time 🟢 Junior 🟡 Mid-level 😶‍🌫️ Therapist Licensed Telehealth Therapist – Mental Health Counselor 🔥 19 hours ago Prosper 1 - 10 🤝 B2B 📚 Education 🌍 Social Impact Website LinkedIn All Job Openings Licensed Telehealth Therapist providing remote therapy for autistic and neurodivergent adults at Prosper Health. Join a mission-driven team dedicated to improving mental health outcomes. 🇺🇸 United States – Remote 💵 $55 - $60 / hour ⏰ Full Time 🟡 Mid-level 🟠 Senior 😶‍🌫️ Therapist 🦅 H1B Visa Sponsor View More Therapist Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs