Director, Regulatory Affairs CMC

DBV Technologies

. Develop and execute global regulatory CMC strategies aligned with changing regulatory and business needs .

Posted 11/3/2026full-timeWarren • New Jersey • United StatesLead💰 $190,000 - $230,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in regulatory CMC strategies, including the preparation and submission of regulatory documents such as IMPDs, INDs, BLAs, and NDAs. Possesses strong leadership skills in cross-functional teams and a thorough understanding of global regulatory requirements for biologics and combination products.

Highest-signal resume keywords

Regulatory CMC Strategy DevelopmentIMPDs, INDs, BLAs, NDAs PreparationVeeva RIM ExperienceGxP Knowledge (GMP, GDP, GCP)Cross-Functional Team Collaboration

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document WritingCMC Regulatory ComplianceFDA Briefing Document PreparationECTD CompilationCombination Products Development

Soft Skills

Strong Verbal CommunicationCritical ThinkingSolution-Oriented Problem SolvingStrategic ThinkingAnalytical Skills

Certifications & Qualifications

US RAC CertificationPMP Certification

Industry Keywords

BiologicsCombination ProductsClinical DevelopmentHealth Authority InterfacingGlobal Regulatory Compliance

Tech Stack

Tools & technologies

Google Cloud PlatformPMP

About the role

Key responsibilities & impact

Develop and execute global regulatory CMC strategies aligned with changing regulatory and business needs
Provide CMC regulatory expertise and leadership for combination biologics/medical device development projects and future commercial products
Lead CMC RA change-control assessments
Support CDMO and QA manufacturing processes from a CMC regulatory perspective
Track health authority commitments
Lead global submissions and ensure compliance with global regulations
Draft, author, review, and submit IMPDs, CMC sections of INDs, BLAs, NDAs, CTAs, FDA briefing documents, MAAs, and other regulatory documents
Prepare Module 3s of BLAs and MAAs for drug/device combination products for food allergies, including peanut allergy, celiac disease, and eosinophilic esophagitis
Prepare CMC sections of INDs and IMPDs for early-stage products
Develop and coordinate CMC submissions to regulatory authorities
Monitor submission progress and coordinate written and verbal responses during meetings
Review CMC documentation for regulatory compliance and appropriateness to the development phase
Implement regulatory processes and procedures, including authoring internal work instructions and company SOPs
Monitor FDA and EMA CMC regulations and guidance and assess implications for development and commercial activities
Support inspection readiness and preparedness at DBV, CDMOs, and contract testing facilities
Collaborate with internal subject matter experts, contract manufacturing organizations, and other stakeholders
Work in cross-functional, matrixed teams and support global scientific and business strategies

Requirements

What you’ll need

Bachelor’s degree in life sciences or equivalent discipline required
Advanced degree (MS, PhD, PharmD) preferred
Minimum 10 years of experience in a regulatory CMC function
Direct responsibility for leading regulatory strategy, writing key documents, and interfacing with health authorities
US RAC and PMP certification a plus
Experience preparing FDA briefing books, IMPDs, INDs, BLAs, NDAs, and related regulatory documents
Experience with CMC regulatory formats and templates for eCTD compilation
Prior experience participating in and writing documents for the FDA and other health authorities
Direct experience developing early- and late-phase programs for combination products, biologics, and/or innovative technologies
Experience participating in cross-functional teams in a matrix environment
Experience working in both large pharmaceutical and small biotechnology organizations
Experience providing strategic regulatory CMC guidance to drug development, registration, and post-market support teams
Current working knowledge of GxP, including GMP, GDP, and GCP
Understanding and working experience with biological products, combination products, and innovative products in clinical development
Strong verbal communication skills and ability to articulate CMC/regulatory concepts across functions and to external audiences
Ability to write high-quality regulatory documents
Experience working with external and internal stakeholders to support global scientific and business strategies
Working knowledge of US, EU, and international regulatory requirements
Critical thinking, solution-oriented problem solving, and strategic thinking skills
Strong analytical and business communication skills
Knowledge of French is a strong plus
Veeva RIM experience is required

Benefits

Comp & perks

Hybrid work arrangement: 3 days per week from the Warren, NJ office and 2 days from home
Global/international travel opportunities (approximately 15% of time)