Director, Regulatory Affairs CMC

About the role

Responsible for the development and execution of global regulatory CMC strategies and ongoing alignment 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 RA perspective, track Health Authority commitments, lead global submissions and ensure compliance with global regulations. Draft, author, review, and submit key regulatory documents including IMPD, CMC sections of INDs, BLAs, NDAs, CTAs, FDA briefing books/documents, MAAs, and other documents as needed. Work with internal and external stakeholders to support inspection readiness and preparedness at DBV and all CDMOs and contract testing facilities.

Responsibilities

• Prepare Module 3s of BLAs and MAAs for drug/device (patch) 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 progress, and coordinate written and verbal responses during meetings.
• Review CMC‑related documentation (e.g., INDs, IMPDs, NDAs, BLAs) for compliance with regulatory guidance and appropriate to development phase.
• Contribute to implementation of regulatory processes and procedures, including developing and authoring internal work instructions and company SOPs.
• Monitor FDA and EMA CMC regulations and guidance to assess and manage relevant changes and implications for current and future development and commercial activities.
• Support inspection readiness and preparedness at DBV and all CDMOs and contract testing facilities.

Qualifications

• Bachelor’s degree in life sciences or equivalent discipline required; advanced degree (MS, PhD, PharmD) preferred.
• US RAC and PMP certification a plus.
• Minimum 10 years’ experience in a regulatory CMC function with direct responsibility for leading regulatory strategy, writing key documents (FDA briefing books, IMPD, IND, BLA, NDA), and interfacing with health authorities (FDA, EMA).
• Ability to work closely with in‑house SMEs and CMOs to acquire critical information for Module 3 and HA responses.
• Capability to set, monitor, and meet CMC Module 3 and other regulatory CMC timelines and deadlines.
• Experience with CMC regulatory formats and templates for eCTD compilation.
• Prior experience participating in and writing documents for 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.
• Broad familiarity and current working knowledge of GxP (GMP, GDP, GCP).
• Understanding and working experience with biological products, combination products, and innovative products in early and late‑phase clinical development.
• Strong verbal communication skills to articulate CMC/regulatory concepts across functions and to external audiences.
• Ability to write high‑quality regulatory documents (briefing documents, IND amendments, IMPD, etc.).
• Experience with external and internal stakeholders to support global scientific and business strategies.
• Demonstrated working knowledge of US, EU, and international regulatory requirements pertinent to this role.
• Exercise critical thinking, solution‑oriented problem solving, strategic thinking with ability to impact and influence in a matrix environment.
• Strong analytical and business communication skills.
• Knowledge of French language is a strong plus.
• Veeva RIM experience is a must.

Skills

• Curiosity: Keep exploring uncharted territories; always ask “why?” and “why not?”
• Courage: Take smart risks, mentor others, be accountable for choices, opinions, and actions.
• Collaboration: Teamwork and spirit; support each other and be equally involved in achieving common goals.
• Credibility: Be transparent, follow through, build trust; educate ourselves about unique technology.

Pay

Salary Range: $190‑230k

Schedule

Hybrid Role: Work from Warren, NJ office 3 days a week / 2 days from home. Additional days in the office as needed. Regular international travel required – 15% of time.