CMC Regulatory Lead — Biologics/Devices (Hybrid)

DBV Technologies; Bernards Township (NJ); Hybride; USD 190 000 - 230 000; Plein temps

Résumé du poste

DBV Technologies seeks a senior regulatory CMC leader to direct global CMC strategies for combination biologics/medical devices, aligning with changing regulatory and business needs. You will lead submissions, author essential documents, and manage health authority interactions.

Hybrid role based in Warren, NJ with 3 days onsite and 2 days remote; travel up to 15% internationally. Strong experience with FDA/EMA and Veeva RIM is essential for this role.

Qualifications

• Bachelor's degree in life sciences or equivalent; advanced degree preferred.
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Responsabilités

• Prepare Module 3s of BLAs and MAAs for drug/device combination products; prepare CMC sections of INDs/IMPDs.
• Coordinate regulatory submissions to FDA/EMA; monitor responses and timelines.
• Review CMC documentation for compliance with guidance; ensure readiness for inspections.
• Develop internal work instructions and SOPs to streamline regulatory processes.
• Monitor regulatory changes and implications for development and commercialization.

Connaissances

CMC leadership

Veeva RIM

Cross-functional

Regulatory strategy

GxP knowledge

French knowledge

Formation

Bachelor's in life sciences

Advanced degree preferred

US RAC and PMP a plus

Outils

Regulatory databases

eCTD compilation

Description du poste

DBV Technologies seeks a senior regulatory CMC leader to direct global CMC strategies for combination biologics/medical devices, aligning with changing regulatory and business needs. You will lead submissions, author essential documents, and manage health authority interactions.

Hybrid role based in Warren, NJ with 3 days onsite and 2 days remote; travel up to 15% internationally. Strong experience with FDA/EMA and Veeva RIM is essential for this role.