Position Summary
The Director, Global Submission Management (GSM) is responsible for the strategic oversight of a portfolio of global regulatory submissions for a growing therapeutic area. This role will lead integrated planning, governance, risk and dependency management, resource and capacity planning, and portfolio-level reporting activities to ensure timely and compliant submissions.
Success in this role depends on applying strong project, program, and portfolio management practices in a highly matrixed biopharmaceutical environment, while rapidly learning the regulatory submission domain and partnering closely with Therapeutic Area Leads, Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, Advertising & Promotion, and other cross-functional stakeholders.
Key Duties & Responsibilities
•Provides project and portfolio management leadership for a defined portfolio of global regulatory submissions, from initiation and planning through execution, submission, and closeout.
•Builds and maintains integrated portfolio and submission plans that define scope, milestones, critical paths, dependencies, decision points, and deliverables across multiple programs.
•Manages Regulatory governance, operating rhythms, and decision forums that enable timely alignment, escalation, and accountability.
•Partners with functional leaders and submission teams to translate regulatory strategy and program priorities into executable plans.
•Creates decision-ready portfolio reporting that clearly communicates status, trends, tradeoffs, capacity constraints, and actions required from leadership.
•Identifies, assesses, and manages cross-functional risks, issues, assumptions, dependencies, and changes that may affect timing, quality, scope, or resource demand.
•Leads, coaches, and develops vendor functional service provider (FSP) resources; establishes clear accountability and supports independent ownership.
•Adopt and scale productivity tools, including AI and automation, to improve planning quality, decision-making, visibility, and operational efficiency.
Education and Experience
•Bachelor's degree in Life Sciences, Regulatory Affairs, Project Management, or related discipline. Advanced degree or certification, such as MBA or PMP, is preferred.
•10+ years of demonstrated leadership of complex projects, programs, or portfolios in pharmaceutical, biotechnology, healthcare, technology, engineering, or other highly regulated industries.
•Demonstrated success leading integrated planning, multi-level governance, and executive reporting at a portfolio or program level.
•Experience managing external vendors, consultants, or functional service providers.
•Prior Regulatory or regulatory submission experience is not required though candidates must demonstrate the learning agility and technical curiosity needed to develop domain fluency quickly.
Knowledge and Skills
•Advanced project, program, and portfolio management capability, including integrated planning, critical path management, dependency management, risk management, change control, and closeout.
•Strong portfolio reporting, scenario planning, resource forecasting, and capacity management skills.
•Proficiency with modern project/portfolio management approaches and tools, such as Smartsheet, MS Project, or comparable platforms.
•Proactively remains up to date on advances in technology, AI, automation, competitive intelligence and changes in the Regulatory environment.
•Excellent executive communication and stakeholder management skills, including the ability to synthesize complexity into concise, decision-ready information.
•Knowledge of pharmaceutical or biotechnology development, regulatory submissions processes is preferred but not required.
Pay Range
$190,400 - $285,600
The range provided is based on what is believed to be 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.
Total Rewards offerings also include inclusive market-leading benefits: medical, dental and vision benefits, 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 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
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.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
