Vertex Pharmaceuticals · 1 month ago
Associate Director - Regulatory Project Management (Contract) 24525
United States
Full-time, Contract
Remote
Lead/Staff, Director/Executive
$90/hr - $100/hr
10+ years expVertex Pharmaceuticals is a leading life sciences company focused on innovative therapies. The Associate Director, Regulatory Submission Management is responsible for planning, managing, and tracking regulatory submissions across various programs, ensuring all deliverables are met and driving timeline risk mitigation.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Oversees complex project and portfolio plans from project initiation to closeout
Drives the definition of the project milestones, tasks, deliverables, key dependencies and resource requirements
Oversees the development of project plans, status reports, issue logs, and other project-related artifacts
Leads strategies for risk mitigation and contingency planning within plan. Efficiently identifies and resolves project issues within the team and drives the resolution to completion
Manages project status, issues, schedule and accomplishments and communicates to various management and stakeholder groups, as needed
Leads and manages members of submission management team
Leads the preparation of necessary reports to drive data-driven resource, budget and trade-off discussions across the GRA function
As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff
Qualification
Required
Expertise in global regulatory filing project management
Expertise in project management tools
Expertise in using Veeva Rim for content plan submissions
Comprehensive understanding of types of Global HA submissions and requirements and guidelines
Ability to drive firm deadlines and adapt quickly to changing requirements and priorities
Excellent organization, written/verbal communication, and attention to detail to persuade managers and leaders to take action
Stakeholder management skills
Ability to balance multiple tasks to meet priorities and timelines
Supervisory/management experience
Bachelor's degree in life sciences or technology area
Typically requires 10+ years of project management experience in regulatory/clinical project management or project management experience in a life sciences company and 2 years of supervisory/management experience, or the equivalent combination of education and experience
Benefits
Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
This role will be eligible for overtime pay, in accordance with federal and state requirements
Company
Vertex Pharmaceuticals
Vertex Pharmaceuticals is focused on the discovery and development of small molecule drugs for the treatment of serious diseases.
5001-10000 employees
H1B Sponsorship
Vertex Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (188)
2024 (150)
2023 (111)
2022 (164)
2021 (112)
2020 (80)
Funding
Current Stage
Public CompanyTotal Funding
$657.31MKey Investors
Janssen Belgium
2024-07-10Post Ipo Secondary· $1.11M
2022-05-17Post Ipo Equity· $50M
2009-12-03Post Ipo Equity· $443M
Leadership Team
Reshma Kewalramani
CEO and President
Nina Devlin
Senior Vice President, Chief Communications Officer
Recent News
2026-01-05
Company data provided by crunchbase