Manager, Regulatory Affairs Operations

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 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.

Warren, New Jersey - 3 days on site

$125-160K

• 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.