DBV Technologies

About the Company

DBV Technologies is a global clinical stage biopharmaceutical company founded by pediatricians who believed that food allergies could one day be treated safely and effectively. We are on a mission to advance epicutaneous immunotherapy using our innovative technology platform, Viaskin(tm), to develop treatment options for immunologic diseases with significant unmet medical need. This mission drives our commitment to the advancement of treatments for patients and their families. That is why we are investigating a potential new class of immunotherapy, epicutaneous immunotherapy (EPIT), that aims to re-educate the immune system of patients through the skin. Today, we are focused on exploring the use of Viaskin to address food allergies, a devastating condition that afflicts millions of patients. As an important milestone in our journey, we hope to offer the first epicutaneous immunotherapy treatment for peanut allergy. Tomorrow, as pioneers, we will continue to explore the broad applications of this potential new class of immunotherapy, including treatments for patients suffering from inflammatory and autoimmune diseases.

Listed Jobs

Company Name

DBV Technologies

Job Title

Manager, Regulatory Affairs Operations

Job Description

Job Title Manager, Regulatory Affairs Operations Role Summary Lead the end‑to‑end regulatory submission lifecycle for biologics, coordinating cross‑functional teams, managing project timelines, and ensuring compliance with global regulatory requirements, with a focus on U.S. BLAs and FDA Advisory Committee preparation. Expectations - Deliver compliant, on‑time submissions for BLAs, INDs, and other regulatory activities. - Develop and maintain strategic submission plans and regulatory logs. - Support post‑submission activities, including health‑authority inquiries and AdComm meetings. Key Responsibilities - Design and execute project timelines; manage global submission plan and scenario planning. - Lead preparation, QC, and electronic publishing of BLAs, INDs, and related documents. - Coordinate FDA AdComm meeting logistics, mock sessions, and key deliverables. - Oversee e‑publishing vendor activities and RIMS archiving; train SMEs on Veeva RIM. - Monitor regulatory changes and competitor activities; assess impact on projects. - Manage third‑party contracts and purchase orders. - Maintain accurate Regulatory Affairs IND submission log. Required Skills - Project management and cross‑functional coordination. - Technical writing and documentation control. - In‑depth knowledge of global submission requirements (eCTD, ICH, FDA, EMA, CTA). - Experience with biologic submissions (BLA, IND, MAA). - Proficiency with Veeva RIM, e‑publishing platforms, and contract management. - Analytical, strategic planning, and communication skills; ability to train others. Required Education & Certifications - Bachelor’s degree in Biochemistry, Chemistry, Biology, or related pharmaceutical field. - Advanced degree (PhD, PharmD, MS) strongly preferred. - Minimum 2 years of regulatory experience in biotech/pharma focusing on biologics. - Valid experience with Veeva RIM and FDA/EMA regulatory processes.

Warren, United states

Hybrid

Junior

19-09-2025