Executive Director, Global Regulatory Operations (Boston, MA)

Role Summary

Executive Director, Regulatory Operations is responsible for leading the teams of publishing, submission management, regulatory information management, compliance and the regulatory management office. This role will create a high quality organization utilizing technology, process and project management to deliver global submissions efficiently and effectively, and drive the strategic framework for how GRA operates as a group with centralized oversight of functional objectives.

Responsibilities

• Leads the Submissions Management & Publishing groups, delivering quality global dossiers to health authorities using effective planning and publishing standards
• Oversees strategic direction of key tools and processes to advance effective dossier delivery in line with industry developments
• Leads Regulatory compliance by driving compliant processes and adherence to standards/procedures; monitors, tracks and implements process improvements by identifying trends and gaps
• Leads the Regulatory Management office, managing operational, strategic, and financial elements of the GRA function (budgets, contracts, Long-Range Plan, resource design, communications, outsourcing partnerships)
• Drives partnership with key submission stakeholders for timelines, document delivery, dashboards, status reporting, and program milestones
• Drives the evolution of technology within GRA, ensuring regulatory developments are incorporated; leads regulatory information management framework, document management and tracking
• Leads the regulatory information/documentation repository/archive team to ensure compliant records and oversight for inspections
• People manager with potential financial/accountability and HR responsibilities for assigned staff

Qualifications

• Required: Bachelor's degree in a relevant life sciences/technology or business discipline
• Required: Typically 15 years of experience in pharmaceutical/life sciences with 7 years of supervisory/management experience building and leading global regulatory operations teams (or equivalent)

Skills

• Proven ability to build and lead 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
• Broad knowledge of global regulatory and compliance environments and future trends
• Strong understanding of the drug development process
• Excellent relationship management with internal stakeholders and external vendor partners
• Excellent organizational and project management skills and strategic thinking

Education

• Bachelor's degree in a relevant life sciences/technology or business discipline