Vertex ยท 3 months ago
Executive Director, Global Regulatory Operations (Boston, MA)
Boston, MA
Full-time
Hybrid
Director/Executive
$244K/yr - $366K/yr
15+ years expVertex is a global biotechnology company that invests in scientific innovation, and they are seeking an Executive Director for Global Regulatory Operations. This role is responsible for leading regulatory operations teams, ensuring compliance, and driving strategic initiatives to deliver quality global submissions efficiently.
Computer Software
Responsibilities
Leads the Submissions Management & Publishing groups, and the delivery of quality global dossiers to HAs utilizing effective planning and publishing standards
Oversees the strategic direction of key tools and processes in the advancement of effective dossier delivery in line with industry tool/process advancements
Leads Regulatory compliance by driving compliant processes and adherence to standards/procedures by GRA. Monitor, track and implement process improvements through identification of trends and gaps
Leads the Regulatory Management office in driving the operational, strategic and financial elements of entire GRA function, including but not limited to budgets, contracts, Long-Range Plan (LRP), resource and organizational design, communications and strategic outsourcing partnerships
Drives the partnership with key submission stakeholders in the development of timelines and document delivery as well as dashboards, reporting of status and coordination of program level milestones related to the submission
Drives the future evolution of technology within GRA, ensuring industry and regulatory developments are incorporated. Leads the regulatory information management framework, document management and tracking within RIM tools/processes
Leads the regulatory information/documentation repository/archive team to ensure compliant records and oversight of key regulatory documentation and commitments for inspections
As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff
Qualification
Required
Proven ability for building and leading high performance global regulatory operations teams
Excellent communication and influencing ability to lead large groups and stakeholders on change initiatives
Ability to keep teams focused on results for the wider organization
Ability to cultivate a high achievement organization; effective as a mentor and coach; able to attract, develop, motivate and retain staff
Credible technology leader able to partner with GIS/innovation groups in evolving business needs
Broad knowledge of the global regulatory and compliance environment in anticipation of future trends and impact
Strong understanding of the drug development process
Excellent relationship management both with internal stakeholders and external vendor partners
Excellent organizational and project management skills and ability to think strategically
Bachelor's degree in a relevant life sciences/technology or business disciplines
Typically requires 15 years experience in pharmaceutical/life sciences industry and 7 years of supervisory/management experience building and leading global regulatory operations teams, or the equivalent combination of education and experience
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 so much more.
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
2-10 employees
H1B Sponsorship
Vertex 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 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase