Global Head of Technical Regulatory & Quality (CMC, Quality & MDD)

Global Head of Technical Regulatory & Quality (CMC, Quality & MDD) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Location: Open Globally At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity.

We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development. That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Global Head, Technical Regulatory & Quality including Global Chemical Manufacturing & Controls, Quality and MDD Services: Provides global oversight and leadership to the teams supporting Chemistry, Manufacturing and Control (CMC), Quality and Medical Device & Diagnostic consulting services. Service provision includes strategic planning and development of CMC content for global dossiers, provision of Canadian QA Unit support, including agent, product release, compliance activities, logistics, and licensing, quality services for medical devices, in vitro diagnostics, and combination products, which also includes development, gap assessment, and remediation of quality systems against core standards and regulations.

Responsible for the strategic direction of the Technical regulatory CMC, Quality and MDD function, including driving business development strategies to grow and maintain the business with new and existing clients and for adapting to changing business needs, expanding to new regions and providing new services. Drives innovation by building the internal capability to position the organization as a leader of high-quality and differentiated service provision.

Responsibilities: Sets the vision and guides the achievement of goals. Impact is on long-term success and continuity of the organization Translates high-level corporate strategy into long-range project plans to gain competitive advantage Oversees the team services in the development and execution of Technical regulatory including Chemistry, Manufacturing and Control (CMC) and MDD development and registration strategies Responsible for interpreting regulatory guidance in chemistry, pharmaceutical development, specifications, method development, manufacturing and validation and ensuring our compliance and for providing informed guidance and direction to cross-functional teams to ensure strategies are developed in compliance with this regulatory guidance for optimal project execution May act as CMC& Quality or MDD expert/representative for the supported organization if partnering with global health authorities Serves as the regulatory CMC, Quality & MDD global representative to company executive management Leads evaluation of new business opportunities and actively involved in Bid Defense meetings including presentations or proposing custom solutions to meet client needs Identifies, leads, and sponsors regulatory technical initiatives, ensuring that expectations are managed and communicated effectively.

Embeds continuous improvement  strategies for operational execution, quality and productivity gains to enhance customer experience and competitive edge Manages and develops staf