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Jobs at ELIQUENT Life Sciences (Now Hiring) — 15 open

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Regulatory Affairs Consultant – Nonclinical Cell & Gene Therapy

United States · Remote OK

$95k–$116k/yr

Mid level

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, dev…

Skills: Nonclinical Development, Regulatory Affairs, Cell And Gene Therapy, Scientific Writing, Pharmacology

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Director/Sr Director, Sales Enablement - Consultant Enablement

United States · Remote OK

$175k–$195k/yr

Senior+

Job Description: Director / Sr. Director, Sales Enablement – Consultant Engagement Location: United States (Remote) – Central or East Coast time zone Salary Range: $175,000 - $195,000 Company Overview: ELIQUE…

Skills: Sales Enablement, Consultant Onboarding, Workforce Mobilization, Process Automation, Capacity Planning

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Owner's Representative Project Manager – GMP Facilities

Costa Mesa, California, United States · On-site

$140/hr–$160/hr

Senior+

We are seeking an experienced Project Manager to lead the delivery of a new GMP-compliant facility, including warehouse, administration, and future manufacturing/QC space. The Project Manager will be responsible for end-…

Skills: Project Management, GMP Compliance, Facility Design, Construction Management, Commissioning And Qualification

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Process Validation Engineer

On-site

Mid level

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 cha…

Skills: Process Validation, Validation Protocol Development & Execution, Smoke Studies, Pharmaceutical Manufacturing Experience, cGMP Knowledge

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Cleaning Validation Engineer

Glendale, California, United States · On-site

Mid level

About Company: Who Are We? ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medic…

Skills: Cleaning Validation, SIP Systems, Pharmaceutical Manufacturing, Regulatory Compliance, Validation Protocols

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Consultant 1

Glendale, California, United States · On-site

Entry level

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 cha…

Skills: Computer System Validation, GMP Compliance, Validation Documentation, Risk Assessment, Data Integrity

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Project Engineer

Glendale, California, United States · On-site

$90k–$100k/yr

Mid level

About Company: Who Are We? ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medic…

Skills: Pharmaceutical Engineering, Commissioning, Validation, cGMP, FDA Regulatory Compliance

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Facilities and Critical Utilities SME

Costa Mesa, California, United States · On-site

$100/hr–$130/hr

Senior+

About Company: Who Are We? ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medic…

Skills: Mechanical Engineering, Utilities Operations, Equipment Validation, HVAC, Steam Systems

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Architectural and Engineering SME

Costa Mesa, California, United States · On-site

$100/hr–$130/hr

Senior

About Company: Who Are We? ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medic…

Skills: Architectural Design Software, Pharmaceutical Manufacturing Processes, Equipment Operation, Regulatory Compliance, Problem Solving

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Project Engineer

Costa Mesa, California, United States · On-site

$90k–$110k/yr

Mid level

About Company: Who Are We? ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medic…

Skills: Pharmaceutical Engineering, Commissioning, Validation, cGMP, FDA Regulatory Compliance

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Part-Time Project Manager – Veeva Vault Modules

United States · Remote OK

$75/hr–$100/hr

Senior

About Company: Who Are We? ELIQUENT Life Sciences is a leading global consulting group delivering regulatory affairs, pharmacovigilance, quality, and compliance solutions that support pharmaceutical, biotechnology, medic…

Skills: Project Management, Stakeholder Management, Risk Management, Resource Coordination, Veeva Vault

ELIQUENT Life Sciences logoELIQUENT Life Sciences

AI Business Analyst

United States · Remote OK

$100k–$125k/yr

Mid level

Location: Remote Company Overview: ELIQUENT Life Sciences is the leading global consulting firm that provides solutions to life science companies researching, developing, and manufacturing innovative products to serve pa…

Skills: AI Implementation, Business Analysis, Change Management, User Acceptance Testing, Data Architecture

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Sr. AI Engineer

United States · Remote OK

$165k–$180k/yr

Senior

Location: Remote Company Overview: ELIQUENT Life Sciences is the leading global consulting firm that provides solutions to life science companies researching, developing, and manufacturing innovative products to serve pa…

Skills: AI Architecture, Data Pipeline Development, Microsoft 365, Azure, Cloud Infrastructure Management

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Regional Business Development Manager

United States · Remote OK

$120k–$140k/yr

Senior

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 cha…

Skills: B2B Sales, Business Development, CRM Utilization, Pipeline Management, Consultative Selling

ELIQUENT Life Sciences logoELIQUENT Life Sciences

Regional Business Development Manager

United States · Remote OK

$120k–$140k/yr

Senior

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 cha…

Skills: B2B Sales, Business Development, CRM Utilization, Pipeline Management, Consultative Selling

ELIQUENT Life Sciences logo

Regulatory Affairs Consultant – Nonclinical Cell & Gene Therapy

ELIQUENT Life Sciences

United States • Remote OK

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Mid level

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  • $95k–$116k/yr
  • Full-time
  • postgraduate degree
  • Posted 14d ago
  • ~40 hrs/week
  • Remote in United States

Responsibilities

The consultant will design and document nonclinical pharmacology and toxicology programs for global regulatory submissions such as IND and BLA. They will also develop nonclinical strategies and monitor global regulatory guidance for advanced therapy products.

Requirements

Requires an advanced degree (PhD, DVM, PharmD, or MD) in a relevant scientific field and 2-5 years of experience in biopharmaceutical or regulatory environments. Strong scientific writing skills and a fundamental understanding of nonclinical drug development are essential.

Full job description

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

Related keywords

Cell & Gene TherapyCGTINDCTABLANDAPharmacologyToxicologyBiodistributionImmunogenicityFDAEMAICHAdvanced Therapy Medicinal ProductsRegulatory ScienceBiotechnology

About ELIQUENT Life Sciences

LinkedInVisit site
Industry
Professional Services
Company size
501-1,000 employees
LinkedIn followers
11,759

We are expert consultants delivering the answers and solutions that life sciences innovators need to gain and maintain market authorization for their products. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to unlock excellence throughout the product lifecycle. We are the convergence of regulatory expertise and technical capabilities across the therapeutic landscape. From thought to finish, concept to commerce, and strategy to execution— ELIQUENT Life Sciences is the singular regulatory resource that clients around the world trust. Together, ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges. Learn more at ELIQUENT.com

Regulatory AffairsLifecycle SolutionsGlobal supportand Advance TherapiesConsultingMedical DeviceProfessional Services
View all jobs at ELIQUENT Life Sciences

About ELIQUENT Life Sciences

LinkedInVisit site
Industry
Professional Services
Company size
501-1,000 employees
LinkedIn followers
11,759

We are expert consultants delivering the answers and solutions that life sciences innovators need to gain and maintain market authorization for their products. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to unlock excellence throughout the product lifecycle. We are the convergence of regulatory expertise and technical capabilities across the therapeutic landscape. From thought to finish, concept to commerce, and strategy to execution— ELIQUENT Life Sciences is the singular regulatory resource that clients around the world trust. Together, ELIQUENT redefines regulatory consulting with a full-service approach and comprehensive solutions that bridge the spectrum of regulatory challenges. Learn more at ELIQUENT.com

Regulatory AffairsLifecycle SolutionsGlobal supportand Advance TherapiesConsultingMedical DeviceProfessional Services
View all jobs at ELIQUENT Life Sciences

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