Global Head of Technical Regulatory, CMC & Quality

ICON; United States; Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive base salary

Health & wellbeing benefits

Retirement and pension plans

Life assurance & disability coverage

Learning & development opportunities

Job summary

ICON seeks a Global Head of Technical Regulatory & Quality to lead CMC, Quality and MDD services worldwide. You will shape regulatory strategy, drive cross-functional collaboration, and oversee the development of global dossiers, QA units, and lifecycle management for drug and device programs.

Lead international stakeholder engagements, guide teams across regions, and advance continuous improvement to deliver high-quality regulatory solutions for clients and patients.

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

Responsibilities

• Sets the vision and guides the achievement of goals.
• 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 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
• 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

Skills

CMC

Quality

MDD

Regulatory strategy

Leadership

Change management

Project planning

Cross-functional collaboration

Stakeholder engagement

Regulatory guidance interpretation

Tools

Global regulatory frameworks

Job description

ICON seeks a Global Head of Technical Regulatory & Quality to lead CMC, Quality and MDD services worldwide. You will shape regulatory strategy, drive cross-functional collaboration, and oversee the development of global dossiers, QA units, and lifecycle management for drug and device programs.

Lead international stakeholder engagements, guide teams across regions, and advance continuous improvement to deliver high-quality regulatory solutions for clients and patients.