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 drive the strategic framework for how GRA operates as a group including centralized oversight of functional strategic objectives.

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

Knowledge

• 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

Education and Experience

• 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