Job Description
Job Title: Vice President, Global Regulatory Affairs Consulting ServicesICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Key Responsibilities:Oversee key regulatory consulting and operational services throughout the entire product lifecycle.Lead strategic growth strategies and ensure continual improvement in the delivery of global regulatory clinical trial support, global regulatory strategic and advisory consulting services, global chemistry manufacturing and controls and quality services, global labeling strategy and operations services, global project management services, and regulatory operations services.Drive functional activities to meet or exceed global revenue and margin targets.Partner with Finance to set budgets, track project revenue, manage costs, and forecast future revenue.Oversee global Business Development activities within regulatory functions, including the bundling and cross-selling of services to customize service offerings to meet client needs.Establish and maintain customer relationships in a consultative, operational, and business development capacity.Build and maintain an optimal global organizational structure, allocating resources to projects and initiatives.Oversee staff hiring, manage performance expectations, develop staff, and plan for succession.Act as a Strategic Regulatory Advisor to customers and internal stakeholders, providing effective and timely regulatory advice.Oversee the preparation, review, and submission of all key regulatory documents, including Marketing Authorization Applications (MAAs), New Drug Applications (NDAs), Clinical Trial Applications (CTAs), and Investigational New Drugs (INDs).Maintain a system of regulatory intelligence at global, regional, and local levels.Represent ICON at external meetings and in regulatory forums.Requirements:Education: A Bachelor's degree in Life Sciences, Business Administration, or a related field is required; a Master's degree or MBA is preferred.Experience: 10+ years of experience in global regulatory affairs within a CRO environment and industry position (preferred).Leadership Skills: Proven leadership experience in managing large, global cross-functional teams, including the ability to drive performance, accountability, and engagement across multiple functions.Financial Acumen: Proven ability to manage budgets, control costs, and ensure financial targets are met. Direct P&L responsibility preferred.Strategic Thinking: Strong strategic and analytical skills, with the ability to develop and execute business strategies that align with organizational goals and drive growth.Regulatory Knowledge: Strong knowledge of global regulatory requirements and processes, including submissions for MAAs, NDAs, CTAs, INDs, and post-licensing activities.Communication Skills: Exceptional communication, negotiation, and interpersonal skills, with the ability to interact effectively with clients, senior management, and cross-functional teams.Adaptability: Ability to thrive in a dynamic and fast-paced environment, managing multiple priorities and driving continuous improvement in processes, systems, and client delivery.What ICON Can Offer:Competitive salary and benefits package.Opportunities for professional growth and development.Collaborative and inclusive work environment.Recognition and rewards for outstanding performance. #J-18808-Ljbffr