Vertex Pharmaceuticals

Vertex Pharmaceuticals

Associate Director, Global Submission Management

Boston, MA · Director

Sponsorship not specified$163k-$245kDetected 12 days ago
Project ManagementStakeholder ManagementRecruitingFDA RegulatoryCRISPRCommunicationRegulatory Affairs

About the role

  • Job Description General 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.
  • 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.

Responsibilities

  • Develops and maintains submission plans, timelines, and tracking across multiple programs
  • Partners with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, and deliverables
  • Identifies, manages, and resolves operational risks affecting submission timelines or quality
  • Supports workload planning and capacity management across the submission portfolio
  • Leads, coaches, and supports submission management staff including vendor functional service providers (FSPs)

Requirements

  • 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.

Skills

  • Strong knowledge of global regulatory submission requirements, processes, and timelines
  • Experience with submission and project management tools and systems
  • Strong organizational, planning, and problem‑solving skills
  • Effective stakeholder management and cross‑functional communication skills
  • Education and Experience:
  • Bachelor's degree in Life Sciences, Regulatory Affairs, Project Management, or a related discipline
  • 7+ years of experience in regulatory submission management, regulatory operations, or regulatory/clinical project management
  • Experience managing routine, regional, and lifecycle regulatory submissions across multiple regions
  • Experience working effectively in matrixed, cross‑functional environments
  • People‑management experience preferred
  • Experience using modern project management and regulatory submission tooling including MS Project, Smartsheet, and Veeva RIM
  • Experience managing submissions in Pulmonary or Cell & Gene Therapy is preferred

Compensation

  • $163,200 - $244,800
  • 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.

Benefits

  • This role is eligible for an annual bonus and annual equity awards.
  • Demonstrates 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 efficiency

Company info

  • The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
  • 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 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 ApplicationAssistance@vrtx.com
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