Director, Global Submission Management

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 190,000 - 286,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Medical benefits

Commuting subsidy

Job summary

Vertex Pharmaceuticals is seeking a Director, Global Submission Management to lead a portfolio of regulatory submissions across development and lifecycle programs. You will partner with strategy, CMC, labeling, publishing, and advertising to drive efficient, compliant submissions globally.

The role requires 10+ years in regulatory submissions with matrixed leadership, strong planning, and risk management skills, and a focus on continuous improvement using emerging technologies and AI-driven

Qualifications

• Experience leading multiple submissions across regions.
• Strong knowledge of global regulatory timelines.
• Experience with project management tools and regulatory submission tooling.
• People-management experience in a matrixed environment.

Responsibilities

• Oversee portfolio of regulatory submissions from planning through closeout.
• Develop submission plans, timelines, and tracking across programs.
• Ensure compliance with submission standards and processes.
• Coordinate with strategy, CMC, labeling, publishing, and promotion teams.
• Coach and develop submission management staff and vendors.

Skills

Regulatory submissions

Global strategy

Project management

Stakeholder management

Risk management

Regulatory affairs

Education

Bachelor's degree

Tools

MS Project

Smartsheet

Veeva RIM

Job description

Job Description General Summary: The 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. 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 closeout
• Develops and maintains submission plans, timelines, and tracking across multiple programs
• Ensures consistent application of submission management standards, tools, and processes
• Partners with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, and deliverables
• Coordinates cross‑functional activities to ensure submission completeness, quality, and compliance
• Identifies, manages, and resolves operational risks affecting submission timelines or quality
• Oversees preparation of submission status updates, issue logs, and portfolio‑level reporting
• Supports workload planning and capacity management across the submission portfolio
• Escalates risks appropriately when submissions approach higher‑impact or higher‑complexity thresholds
• Leads, coaches, and supports submission management staff including vendor functional service providers (FSPs)
• Contributes to continuous improvement, knowledge sharing, and talent development within submission management
• 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
• Proactively 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 timelines
• Experience with submission and project management tools and systems
• Ability to manage multiple concurrent submissions and competing priorities
• Strong organizational, planning, and problem‑solving skills
• Effective stakeholder management and cross‑functional communication skills
• Ability to drive execution consistency, compliance, and operational efficiency

Education and Experience

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Project Management, or a related discipline
• 10+ years of relevant experience with demonstrated leadership across submission portfolios
• Experience managing routine, regional, and lifecycle regulatory submissions across multiple regions
• Experience working effectively in matrixed, cross‑functional environments
• People‑management experience
• Experience using modern project management and regulatory submission tooling including MS Project, Smartsheet, and Veeva RIM

Pay Range: $190,400 - $285,600

Disclosure 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 Eligible

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 Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

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 [e-mail]

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion‑dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1‑mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH‑dependent Cushing’s syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.