Manager, Regulatory Affairs Operations

DBV Technologies; Bernards Township (NJ); On-site; USD 125,000 - 160,000; Full time

Job summary

DBV Technologies in Warren, NJ, is seeking a Manager of Regulatory Affairs Operations to lead the preparation, coordination, and submission of regulatory filings with a strong U.S. FDA focus.

You will develop submission content plans, manage timelines, and ensure high-quality, compliant packages across BLAs and INDs. You will collaborate with CMC, Nonclinical, Clinical, and Labeling teams, drive RIMS/Veeva adoption, and uphold eCTD standards while coordinating external vendors and publishing

Qualifications

• Bachelor’s degree in biochemistry, chemistry, biology, or a related pharmaceutical field is required; an advanced degree (PhD, PharmD, MS) is strongly preferred.
• Minimum of 3–5 years regulatory experience in biotech/pharma, focus on biologics preferred.
• Experience supporting U.S. FDA submissions (BLA, IND) and strong understanding of eCTD requirements.
• Demonstrated experience in submission planning, coordination, and lifecycle management.
• Must have experience with Regulatory Information Management Systems Veeva RIM.
• Knowledgeable with ePublishing processes and vendor coordination.

Responsibilities

• Develop and manage submission content plans, preparing regulatory submission documents (cover letters, FDA forms).
• Oversee submission timelines and publishing activities.
• Coordinate regulatory submissions, including BLAs, INDs, and responses to Health Authority requests.
• Collaborate with CMC, Nonclinical, Clinical, Labeling and other teams to align submission content and timelines.
• Support preparation, submission, and defense of major U.S. marketing applications (e.g., BLA).
• Participate in quality control activities for regulatory submissions to ensure accuracy and compliance with eCTD standards.
• Manage regulatory submission records and archiving in RIMS, and support Veeva RIM implementation.

Skills

Regulatory submissions

Project management

Attention to detail

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree in biochemistry, chemistry, biology, or related pharmaceutical field

Advanced degree (PhD, PharmD, MS) preferred

Tools

Veeva RIM

eCTD knowledge

ePublishing coordination

Job description

The Manager Regulatory Affairs Operations is responsible for supporting the preparation, coordination, and submission of regulatory filings to global health authorities, with a strong focus on U.S. FDA submissions. This role collaborates closely with Regulatory Affairs and cross-functional teams to ensure the timely and compliant delivery of high‑quality regulatory submissions, including major marketing applications (e.g., BLAs) and investigational applications (e.g., INDs). The role requires a highly detail-oriented, proactive individual who can effectively manage multiple priorities in a fast-paced environment.

Key Responsibilities

• Key responsibilities include developing and managing submission content plans, preparing regulatory submission documents (e.g., cover letters, FDA Forms), overseeing submission timelines, and coordinating publishing activities.
• Regulatory Submission Planning & Strategy
• Collaborate with cross-functional teams to develop and maintain comprehensive global submission content plans, including dossier structure, key deliverables, timelines, and projected approval milestones.
• Conduct scenario planning to evaluate alternative regulatory strategies and recommend approaches to optimize submission timelines and mitigate risks.
• Regulatory Submissions Coordination
• Lead the coordination and execution of regulatory submissions, including BLAs, INDs, and responses to Health Authority requests.
• Partner with functional teams (CMC, Nonclinical, Clinical, Labeling, and others) to ensure alignment on submission content and timelines.
• Support the preparation, submission, and defense of major U.S. marketing applications (e.g., BLA).
• Submission Quality Control
• Participate in and/or lead quality control (QC) activities for regulatory submissions to ensure accuracy, completeness, and compliance with regulatory requirements (e.g., eCTD standards).
• Ensure all submission components meet internal quality standards and are delivered within established timelines.
• Regulatory Information Management Systems (RIMS)
• Manage regulatory submission records, documentation, and archiving within the Regulatory Information Management System (RIMS) for assigned programs.
• Support the organization’s transition to and optimization of Veeva RIM, including process alignment and user adoption.
• Regulatory Intelligence
• Monitor evolving regulatory requirements and industry trends, particularly related to ePublishing and submission standards.
• Assess potential impact of regulatory changes on ongoing and planned submissions and communicate implications to stakeholders.
• Vendor & Contract Management
• Support management of external vendors, including ePublishing providers and other regulatory service partners.
• Assist with contract administration, including creation and tracking of purchase orders and budget monitoring.

Location

Warren, New Jersey - 3 days on site

Salary Range

$125-160K

Qualifications

• Bachelor’s degree in biochemistry, chemistry, biology, or a related pharmaceutical field is required; an advanced degree (PhD, PharmD, MS) is strongly preferred.
• Minimum of 3-5 years of regulatory experience in the biotech or pharmaceutical industry, with a focus on biologics, is strongly preferred.
• Experience supporting U.S. FDA submissions (e.g., BLA, IND) and strong understanding of eCTD requirements.
• Demonstrated experience in submission planning, coordination, and lifecycle management.
• Must have experience with Regulatory Information Management Systems Veeva RIM
• Knowledgeable with ePublishing processes and vendor coordination.
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• Strong attention to detail, organization, and project management skills.
• Ability to manage multiple complex projects with competing deadlines.
• Proactive mindset with strong problem‑solving capabilities.
• Excellent communication and cross‑functional collaboration skills.

Behavioral Skills

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.