Job Description
VP, Global Regulatory Affairs Consulting Services/ Ireland & UK / Hybrid
ICON 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.
This is an exciting opportunity to join ICON as the VP of Global Regulatory Affairs to lead core global regulatory functions in support of outstanding delivery of regulatory services to our clients. Support extends the entire product lifecycle from development through to lifecycle management and provides regulatory guidance to our internal global clinical delivery functions and business development within ICON. The role requires developing strategic regulatory approaches, commercial management to drive revenue and manage budgets and utilization as well as overseeing regulatory submissions, ensuring compliance with legal and regulatory standards, and primarily ensuring our services surpass our client expectations. As a key member of the leadership team, the VP will foster strong client relationships, build and manage global teams, and maintain ICON's reputation as a regulatory leader in the industry.
What you will do
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
- Regulatory Operations Services
- Regulatory Information Management
- Publishing
- Technology Management and Support
- Global Medical Devices
Revenue & Budget Management:
- 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.
Business Development:
- Oversee global Business Development activities within regulatory functions including the bundling and cross selling of services to customize service offerings to meet client needs.
- Support broader ICON Business Development needs and build service offering awareness internally and externally.
- Establish and maintain customer relationships in a consultative, operational, and business development capacity.
Organizational Leadership:
- 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.
- Ensure all projects are delivered on time, to quality expectations, and in compliance with ethical, legal, and regulatory standards.
Regulatory Delivery:
- 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 such as Marketing Authorization Applications (MAAs), New Drug Applications (NDAs), Clinical Trial Applications (CTAs), and Investigational New Drugs (INDs), Lifecycle management and Maintenance Submissions.
- Provide regulatory input and oversee regulatory agency meetings.
- Maintain a system of regulatory intelligence at global, regional, and local levels.
- Oversee the development, implementation, and maintenance of validated technology and operational processes to support future operations.
Executive Reporting:
- Apprise executive management of key regulatory developments within the industry that may impact ICON's business.
- Represent ICON at external meetings and in regulatory forums.
Compliance & Process Improvement:
- Ensure corrective and preventative actions are taken in a timely manner to address issues.
- Recognize and adhere to ICON's values centered around People, Clients, and Performance.
- Foster a culture of process improvement aimed at streamlining processes, adding value to the business, and meeting client needs.
Your Profile
- 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. Experience in financial reporting and analysis to support business objectives.
- 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.
- Located - Ireland or UK
- Travel Able to travel internationally