Strategic CMC Regulatory Director – Global Biologics/Devices

DBV Technologies; Virginia; Hybride; USD 190 000 - 230 000; Plein temps

Résumé du poste

DBV Technologies seeks a senior regulatory CMC leader to steer global CMC strategy and submissions for drug-device combos. You will collaborate with internal SMEs and CMOs, draft essential documents, and ensure readiness for audits and inspections.

You will manage Module 3 activities, monitor evolving FDA/EMA guidance, and mentor teams across development stages while traveling internationally and working in a hybrid Warren, NJ setting.

Qualifications

• Bachelor’s degree in life sciences; US RAC and PMP certification a plus.
• Minimum of 10 years’ experience in regulatory CMC with leadership in strategy and document writing.
• Experience interfacing with health authorities (FDA/EMA) is required.

Responsabilités

• Prepare Module 3s of BLAs and MAAs for drug/device combination products.
• Develop and coordinate CMC submissions to regulatory authorities and respond to inquiries.
• Review CMC-related documentation for regulatory compliance across development stages.
• Contribute to regulatory processes, SOPs, and internal work instructions.
• Monitor FDA and EMA CMC regulations and advise on implications for programs.

Connaissances

Regulatory strategy

Cross-functional collaboration

Regulatory writing

FDA/EMA experience

Formation

Bachelor’s degree in life sciences

US RAC certification

PMP certification

Outils

Veeva RIM

Description du poste

DBV Technologies seeks a senior regulatory CMC leader to steer global CMC strategy and submissions for drug-device combos. You will collaborate with internal SMEs and CMOs, draft essential documents, and ensure readiness for audits and inspections.

You will manage Module 3 activities, monitor evolving FDA/EMA guidance, and mentor teams across development stages while traveling internationally and working in a hybrid Warren, NJ setting.