Global CMC Regulatory Lead – Biologics/Devices (Hybrid)

DBV Technologies; Bernards Township (NJ); Hybrid; USD 190,000 - 230,000; Full time

Job summary

DBV Technologies in Warren, NJ is seeking a senior regulatory CMC leader to drive global strategies for combination biologics/medical device programs and future commercial products. You will provide CMC expertise, lead health authority interactions, and oversee global submissions.

The role is hybrid—work from Warren, NJ office three days a week and two days from home, with regular international travel (15%).

Qualifications

• 10+ years in regulatory CMC with leadership in strategy and health authority interactions
• Experience writing FDA briefing books, INDs, BLAs, NDA, IMPD
• Experience with combination products and biologics
• GxP knowledge and global regulatory familiarity
• US RAC and PMP certification a plus

Responsibilities

• Prepare Module 3s for drug/device combination products and CMC sections of INDs and IMPDs
• Coordinate CMC submissions to regulatory authorities; monitor progress and respond to questions
• Review CMC-related documentation for regulatory compliance and phase readiness
• Contribute to regulatory processes, write internal work instructions and SOPs
• Monitor FDA/EMA CMC regulations and implications for development and commercialization

Job description

DBV Technologies in Warren, NJ is seeking a senior regulatory CMC leader to drive global strategies for combination biologics/medical device programs and future commercial products. You will provide CMC expertise, lead health authority interactions, and oversee global submissions.

The role is hybrid—work from Warren, NJ office three days a week and two days from home, with regular international travel (15%).