New · posted Nov 5
ICON · Pharmaceuticals
Global Head of Technical Regulatory & Quality (CMC, Quality & MDD)
- Remote, US
- Remote
- Full-time
- VP & Executive
The role
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.
What you need
• 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
What you'll do
- 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
Pay and benefits
ICON didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Benefits of Working in ICON
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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Equal opportunity, accessibility and legal noticesICON's statements, word for word
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
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.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
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.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
VP & Executive roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $315,625 | $328,750 | $334,375 |
Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 83 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not ICON's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- GMP and compliance3
- Regulatory submissions3
- Quality systems and risk3
- Clinical trial conduct2
- Lab testing and methods1
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
ICON on Regulatory Jobs
- 140
- Open roles
- 65
- Distinct roles
- 32
- Locations
By discipline
- Clinical129 92%
- Quality7 5%
- Regulatory4 3%
By level
- Associate & Specialist59 42%
- Senior & Principal58 41%
- Manager18 13%
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Global Head of Technical Regulatory & Quality (CMC, Quality & MDD) at ICON
Open until filled.