Filing Excellence Program Manager

Position Overview:

Beam is seeking an experienced Director, Filing Excellence Program Manager to provide project leadership for major global regulatory submissions, including Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and associated Health Authority review activities. Working closely with Regulatory Affairs and cross-functional leaders, this role will translate regulatory strategy into an integrated execution plan that aligns content development, data availability, submission readiness, and review-cycle activities.

This individual will drive the end-to-end submission operating model, establishing the critical path, governance, decision-making forums, risk management, and readiness processes required to deliver high-quality submissions on time. The Director will serve as a central point of integration across Regulatory, Clinical, Biostatistics, Data Management, CMC, Nonclinical, Safety, Quality, Medical Writing, Labeling, and Regulatory Operations.

The ideal candidate is an experienced regulatory project leader who combines deep submission execution experience with strong cross-functional leadership, operational judgment, and the ability to create clarity and drive decisions in complex, fast-moving environments.

Responsibilities:

• Drive integrated submission planning and execution by establishing and leading the end-to-end submission plan and critical path, including content development, data availability, review and approval cycles, publishing, submission, and Health Authority review.
• Translate regulatory strategy into an executable operating plan by partnering with Regulatory Affairs and functional leaders to define deliverables, ownership, milestones, decision points, dependencies, and readiness criteria across submission modules and workstreams.
• Lead cross-functional submission readiness across Regulatory, Clinical, Biostatistics, Data Management, CMC, Nonclinical, Safety, Quality, Medical Writing, Labeling, and Regulatory Operations, ensuring alignment of data, analyses, documents, and submission content.
• Drive critical submission milestones, including readiness for pre-submission Health Authority interactions, content completion, cross-functional reviews and approvals, quality-control activities, publishing handoffs, and final submission readiness assessments.
• Establish submission governance and decision-making forums, with clear decision rights, escalation pathways, risk management, and executive reporting that enable rapid issue resolution and informed leadership decisions.
• Provide clear visibility to submission readiness through fit-for-purpose dashboards, milestone tracking, risk and decision logs, and executive reporting focused on critical-path status, emerging risks, resource constraints, and decisions required.
• Lead rolling-submission planning and execution (when applicable) by defining module sequencing and associated content, data, review, approval, and publishing dependencies; identify timing risks and drive mitigation and recovery planning.
• Lead Health Authority review-cycle execution, including cross-functional planning and rapid-response activities for information requests, labeling, inspection readiness, commitments, and other critical milestones through approval.
• For FDA submissions, help integrate U.S. Prescribing Information (USPI), Pre-License Inspection (PLI), Bioresearch Monitoring (BIMO) inspection readiness, and launch readiness activities into the overall submission and review-cycle plan, ensuring clear ownership, dependencies, decision points, and cross-functional alignment through approval and launch.
• Drive resource and capacity planning for submission-critical workstreams, partnering with functional leaders to establish priorities, resolve competing demands, and implement recovery plans when needed.
• Build scalable submission-management capabilities by establishing standardized plans, dashboards, workflows, and reporting practices using Smartsheet and other project-management tools.

Qualifications:

• BS in a scientific, technical, or related discipline required; advanced degree preferred.
• Typically 12 + years of experience with 10+ years of biotechnology or pharmaceutical industry experience, including significant leadership of complex, cross-functional programs or projects.
• Direct, hands-on experience leading the planning and execution of at least one major marketing application, preferably a BLA, through submission and Health Authority review.
• Strong understanding of eCTD structure, submission content dependencies, regulatory operations, and the end-to-end path from content development through review, approval, publishing, and submission.
• Demonstrated ability to lead integrated submission planning, governance, readiness assessments, risk management, and executive-level reporting.
• Proven ability to influence across functions and organizational levels, drive decisions without direct authority, and maintain execution discipline in complex, fast-paced environments.
• Experience managing Health Authority information requests, inspection-readiness activities, labeling, or other post-submission review activities strongly preferred.
• Experience with cell or gene therapy programs and accelerated development or approval pathways preferred.
• Proficiency with Smartsheet or comparable project-management, collaboration, and portfolio-planning tools.
• Strong facilitation, problem-solving, communication, and leadership skills, with the ability to translate complex information into clear priorities, actions, and decisions.
• Candidates must live locally and be able to work from Beam's Cambridge location 1 to 3 days per week as needed.

Beam Pay Range 210000 - 260000 USD