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.
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.
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.
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).Proven leadership experience in managing large, global cross-functional teams, including the ability to drive performance, accountability, and engagement across multiple functions.
Strong strategic and analytical skills, with the ability to develop and execute business strategies that align with organizational goals and drive growth.
Exceptional communication, negotiation, and interpersonal skills, with the ability to interact effectively with clients, senior management, and cross-functional teams.
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 UKTravel Able to travel internationally