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

KCR Placement; Dublin; Hybrid; EUR 220,000 - 260,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee assistance programme

Life assurance

Country-specific optional benefits

Job summary

ICON plc is recruiting a Global Head of Technical Regulatory & Quality (CMC, Quality & MDD) to lead global teams overseeing CMC, Quality and Medical Device & Diagnostic consulting, with strategic direction and business development across regions.

The role drives innovative regulatory strategies, ensures adherence to global standards, and partners with executive leadership to expand services and client engagements worldwide.

Qualifications

• Expert understanding of scientific principles and regulatory 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.

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 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 Knowledge

Quality Systems

Regulatory Strategy

Leadership

Cross-Functional

Job description

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 ofCMC 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 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

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 of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

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