Associate Director, Global Submission Management

Job DescriptionGeneral Summary:The Associate Director, Global Submission Management (GSM) is responsible for the strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs. This role will manage submissions for development‑stage, lifecycle, regional, and post‑approval, as well as supporting activities required to enable, maintain, and advance global product registrations. The disease area focus of this role will be Pulmonary or Cell & Gene Therapy.This role ensures routine, regional, and lifecycle submissions are delivered efficiently, compliantly, and predictably in alignment with global regulatory strategies and operational objectives. This role partners closely with Major Submission Leads, Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion functions to support coordinated submission planning, execution consistency, and steady‑state portfolio throughput.Key Duties and Responsibilities:Provides oversight for a defined portfolio of regulatory submissions, from planning through submission and closeoutDevelops and maintains submission plans, timelines, and tracking across multiple programsEnsures consistent application of submission management standards, tools, and processesPartners with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, and deliverablesCoordinates cross‑functional activities to ensure submission completeness, quality, and complianceIdentifies, manages, and resolves operational risks affecting submission timelines or qualityOversees preparation of submission status updates, issue logs, and portfolio‑level reportingSupports workload planning and capacity management across the submission portfolioEscalates risks appropriately when submissions approach higher‑impact or higher‑complexity thresholdsLeads, coaches, and supports submission management staff including vendor functional service providers (FSPs)Contributes to continuous improvement, knowledge sharing, and talent development within submission managementDemonstrates the ability to effectively adopt and leverage emerging technologies, including AI driven tools, and maintains a continuous learning mindset to strengthen GSM decision-making and operational efficiencyProactively remains up to date on advances in technology, AI, automation, competitive intelligence and changes in the Regulatory environment.Knowledge and Skills:Strong knowledge of global regulatory submission requirements, processes, and timelinesExperience with submission and project management tools and systemsAbility to manage multiple concurrent submissions and competing prioritiesStrong organizational, planning, and problem‑solving skillsEffective stakeholder management and cross‑functional communication skillsAbility to drive execution consistency, compliance, and operational efficiencyEducation and Experience:Bachelor’s degree in Life Sciences, Regulatory Affairs, Project Management, or a related discipline7+ years of experience in regulatory submission management, regulatory operations, or regulatory/clinical project managementExperience managing routine, regional, and lifecycle regulatory submissions across multiple regionsExperience working effectively in matrixed, cross‑functional environmentsPeople‑management experience preferredExperience using modern project management and regulatory submission tooling including MS Project, Smartsheet, and Veeva RIMExperience managing submissions in Pulmonary or Cell & Gene Therapy is preferred#LI-HybidPay Range:$163,200 - $244,800Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to 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) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex 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 select2. On-Site: work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-HybridCompany InformationVertex 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 person's 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 View email address on click.appcast.io: Boston, MAType: Full time