DBV Technologies · 1 day ago
Regulatory Affairs Operations - BLA Compilation & QC Support (contractor)
Warren, NJ
Contract
Hybrid
Entry, Mid Level
$50/hr - $75/hr
2+ years expDBV Technologies is a global clinical stage biopharmaceutical company focused on advancing epicutaneous immunotherapy. The contractor will provide Regulatory Affairs Operations support with an emphasis on BLA compilation and quality control activities, contributing to the preparation and QC of regulatory submission components.
BiopharmaBiotechnologyHealth CareHealth Diagnostics
Responsibilities
Support assembly and maintenance of BLA submission modules (including CMC, nonclinical, and clinical sections) ensuring adherence to regulatory guidance and company templates
Perform detailed QC of submission documents for completeness, formatting, consistency, and compliance with regional and global regulatory requirements (e.g., FDA eCTD specifications)
Coordinate with document owners and subject matter experts to resolve content discrepancies, missing elements, cross-references, and citation issues
Prepare and review annexes, tables of contents, file naming conventions, and submission metadata to meet eCTD and company standards
Track submission deliverables, version control, and documentation of QC findings; generate and manage QC reports and corrective action follow-up
Support creation and maintenance of submission checklists, compilation plans, and standard operating procedures related to BLA assembly and QC processes
Collaborate with Regulatory Affairs, CMC, Clinical, Quality Assurance, and external vendors to facilitate timely submission readiness and filing
Participate in submission planning meetings, readiness reviews, and mock inspections as requested
Contribute to continuous improvement initiatives to streamline compilation and QC workflows and enhance submission quality
Qualification
Required
Bachelor's degree in a life science, pharmacy, regulatory science, or related discipline
2+ years' experience in regulatory submissions compilation or document QC within pharmaceutical, biotech, or CRO settings; specific BLA or biologics submission experience preferred
Practical knowledge of eCTD specifications and submission lifecycle processes
Familiarity with regulatory agency requirements (FDA) and guidance relevant to BLAs and biologics
Strong attention to detail with demonstrated experience performing document-level and cross-document QC
Proficient with document management systems, MS Office (Word, Excel), and PDF editing/annotation tools; experience with submission publishing software is a plus
Excellent organizational skills, with the ability to prioritize tasks and meet tight deadlines in a matrixed environment
Effective written and verbal communication skills in English (United States)
Demonstrated ability to work collaboratively with cross-functional teams and external partners
Preferred
Specific BLA or biologics submission experience preferred
Company
DBV Technologies
DBV Technologies focuses on the development of innovative products for the diagnosis and treatment of food allergies.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$453.37MKey Investors
MPM BioImpactSofinnova Partners
2025-10-06Post Ipo Secondary· $30M
2025-03-27Post Ipo Equity· $180.05M
2022-06-09Post Ipo Equity· $192.21M
Leadership Team
Daniel Tasse
CEO / Directeur General
Virginie Boucinha
Chief Financial Officer
Recent News
2026-01-02
Company data provided by crunchbase