Global Head, Regulatory, CMC & Quality Strategy

Meeveem Limited; Reading; On-site; GBP 180,000 - 240,000; Full time

Job summary

ICON plc seeks a Global Head of Technical Regulatory & Quality (CMC, Quality & MDD) to provide global oversight and leadership for CMC, Quality and Medical Device & Diagnostic consulting services. You will plan strategically, develop dossiers for global submissions, and support QA activities across devices and diagnostics.

You will drive the strategic direction, expand into new regions, and lead cross-functional teams to deliver high-quality services while maintaining strong client

Qualifications

• Expert understanding of regulatory CMC, Quality and MDD requirements for global drug development.
• Expert knowledge of review and approval processes by Health Authorities / Notified Bodies.
• Expertise in drug and device development, product maintenance and global regulations and operations.
• Ability to lead international Agency Interactions and product development meetings.
• Advanced leadership including change management, people development and strategic influence.

Responsibilities

• Sets the vision and guides the achievement of goals with long-term impact.
• Translates strategy into long-range project plans to gain competitive advantage.
• Oversees CMC, Quality and MDD development strategies and registration activities.
• Interprets regulatory guidance for cross-functional teams to ensure compliant execution.
• Represents regulatory CMC/Quality to executive management and stakeholders.
• Leads business development efforts and client engagements with strategic focus.
• Drives continuous improvement and risk management across functions.

Skills

CMC regulatory leadership

Quality regulatory excellence

Global regulatory strategy

International agency interactions

Strategic leadership

People development

Regulatory risk management

Job description

ICON plc seeks a Global Head of Technical Regulatory & Quality (CMC, Quality & MDD) to provide global oversight and leadership for CMC, Quality and Medical Device & Diagnostic consulting services. You will plan strategically, develop dossiers for global submissions, and support QA activities across devices and diagnostics.

You will drive the strategic direction, expand into new regions, and lead cross-functional teams to deliver high-quality services while maintaining strong client