Global CMC Regulatory Lead — Biologics/Devices (Hybrid)

DBV Technologies

Virginia

Hybride

USD 190 000 - 230 000

Plein temps

14 jours+

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Résumé du poste

DBV Technologies seeks a senior regulatory CMC leader to drive global strategies for biologics/combination products and guide readiness for inspections. You will draft, review, and submit CMC sections for BLAs, NDAs, INDs, and related documents while coordinating with health authorities and CMOs.

The role requires 10+ years in regulatory CMC, strong cross-functional collaboration, and expertise with FDA/EMA guidelines, and Veeva RIM proficiency. Hybrid work with international travel is expected.

Qualifications

Bachelor’s degree in life sciences or equivalent; MS/PhD preferred.
US RAC and PMP certification a plus.
10+ years in regulatory CMC leading strategy and health authority interactions.
Experience with FDA/EMA submissions and cross-functional teams.
Ability to work with CMOs and SMEs to gather data.

Responsabilités

Prepare Module 3s of BLAs and MAAs for drug/device (patch) combination products for food allergies including peanut allergy, celiac disease, and eosinophilic esophagitis plus prepare the 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.
Review CMC-related documentation (INDs, IMPDs, NDAs, BLAs) for regulatory compliance and suitability for development phase.
Contribute to implementing regulatory processes and procedures, including internal SOPs.
Monitor FDA and EMA CMC regulations to assess changes and implications for development and commercialization.