Director, Major Application Submission Management

Job Description

The Director Major Application Submission Management is accountable for the strategic oversight and execution of a defined portfolio of enterprisecritical major global regulatory applications across complex development and lifecycle programs. This role leads endtoend submission planning and delivery for highimpact 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 patientaccess 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 seniorlevel decision support.

Key Duties & Responsibilities:

• Provides strategic leadership and oversight for submissions from planning through submission and closeout
• Drives development and execution of comprehensive submission plans timelines and portfoliolevel reporting
• Partners with Global Regulatory Strategy Regulatory CMC Labeling Publishing and Advertising & Promotion to define submission scope milestones deliverables and dependencies
• Ensures alignment across crossfunctional 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 datadriven analyses and reports to support resourcing prioritization and tradeoff decisions
• Communicates submission progress risks and outcomes clearly to senior leadership and governance bodies

Knowledge and Skills:

• 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 changemanagement 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 problemsolving capabilities

Education and Experience Level:

• Bachelors 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 peoplemanagement experience and ability to lead highperforming teams
• Experience operating in highly matrixed crossfunctional environments

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at