Director, Major Application Submission Management

Vertex Inc. • Boston, MA

11d • Hybrid

About The Position

The Director, Major Application Submission Management is accountable for the strategic oversight and execution of a defined portfolio of enterprise‑critical, major global regulatory applications across complex development and lifecycle programs. This role leads end‑to‑end submission planning and delivery for high‑impact filings, ensuring submissions are executed efficiently, compliantly, and in alignment with global regulatory and business strategies. This role is scoped to major health authority applications (e.g., NDA, BLA, MAA, and equivalents) where submission outcomes have material regulatory, commercial, and patient‑access implications. The Director serves as a strategic partner to Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion functions, driving integrated submission plans, proactive risk management, and senior‑level decision support.

Requirements

• Expertise in global regulatory submission planning and execution
• Strong knowledge of health authority submission requirements, guidelines, and timelines
• Experience with submission and project management tools and systems
• Strong stakeholder management, influence, and change‑management skills
• Demonstrated ability to manage multiple complex priorities and drive firm deadlines
• Excellent written and verbal communication skills with the ability to engage senior leadership
• Strong organizational, analytical, and problem‑solving capabilities
• Bachelor’s degree and/or Advanced degree in Life Sciences, Regulatory Affairs, Project Management, or a related discipline.
• 10+ years’ experience in regulatory submission management, regulatory operations, or regulatory/clinical project management
• Demonstrated experience leading major global regulatory applications (e.g., NDA, BLA, MAA or equivalents)
• Proven people‑management experience and ability to lead high‑performing teams
• Experience operating in highly matrixed, cross‑functional environments

Responsibilities

• Provides strategic leadership and oversight for submissions from planning through submission and closeout
• Drives development and execution of comprehensive submission plans, timelines, and portfolio‑level reporting
• Partners with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, deliverables, and dependencies
• Ensures alignment across cross‑functional teams and drives accountability for submission deliverables tied to major filings
• Leads identification, escalation, and mitigation of submission risks; develops contingency and scenario plans for complex programs
• Serves as senior escalation point for complex submission issues and drives resolution to completion
• Guides preparation of data‑driven analyses and reports to support resourcing, prioritization, and trade‑off decisions
• Communicates submission progress, risks, and outcomes clearly to senior leadership and governance bodies

Benefits

• medical, dental and vision benefits
• generous paid time off (including a week‑long company shutdown in the Summer and the Winter)
• educational assistance programs including student loan repayment
• a generous commuting subsidy
• matching charitable donations
• 401(k)

What This Job Offers

• Job Type: Full-time
• Career Level: Director