[Hiring] Global Head of Technical Regulatory & Quality @ICON plc

Role Description

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.
  • 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.
  • 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 impacting long-term success and continuity of the organization.
• Translates high-level corporate strategy into long-range project plans to gain competitive advantage.
• Oversees team services in the development and execution of Technical regulatory including CMC and MDD development and registration strategies.
• Responsible for interpreting regulatory guidance in chemistry, pharmaceutical development, specifications, method development, manufacturing and validation.
• 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 staff including staff professional development and project oversight accountability.
• Sets department strategy goals and objectives.
• Defines and tracks functional KPIs. Performs departmental health checks and continually seeks opportunities for improvement in team processes and performance.
• Builds teams across functions and geographies with individuals who have the right technical, scientific and leadership skills and experience to deliver on consulting services and key organizational goals.
• Develops capabilities and processes to expand business opportunities and involved in all activities to attract new client work.
• Anticipates, identifies, assesses and prioritizes risks to business and client goals, and develops strategies to manage and mitigate the impact of risks.

Qualifications

• Expert understanding of scientific principles and regulatory technical CMC, Quality and MDD requirements relevant to global drug development and post marketing support.
• Expert knowledge of review and approval processes of applicable regulatory Health Authorities / Notified Bodies.
• Expertise in pharmaceutical drug and device development, product maintenance and global regulations and operations pertaining to product development strategy, registration and maintenance.
• Ability to serve as lead in international Agency Interactions and product development meetings.
• Advanced leadership skills including change management, people development, strategic thinking and influencing.
• Ability to manage time and resources required for multiple projects.
• Excellent ability to plan, organize and deliver multiple or complex projects, according to agreed deadlines.
• Excellent ability to understand complex issues and propose creative and achievable solutions.

Benefits

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.