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.

As a Senior Global Regulatory Scientist at ICON, you will prepare strategy and coordinate global clinical trial regulatory deliverables in compliance with ICON policies, applicable regulations, and ICH-GCP principles.

What You Will Do:

• Recognize, exemplify, and adhere to ICON’s values, centered on People, Clients, and Performance.

• Contribute to a culture of continuous process improvement, focusing on efficiency, value creation, and client needs.

• Independently manage global clinical trial regulatory deliverables, including complex studies, ensuring compliance with applicable regulations, guidelines, SOPs, contractual timelines, and budgets.

• Serve as Regulatory Functional Lead for assigned clinical trial projects, overseeing the regulatory project team.

• Develop and implement global clinical trial submission strategies in collaboration with stakeholders.

• Prepare, review, and maintain regulatory plans and core regulatory documentation, ensuring alignment with scientific, strategic, therapeutic area, and study-specific requirements.

• Coordinate submissions to regulatory agencies (RAs), central ethics committees (CECs), and country-specific authorities.

• Maintain accuracy and completeness of regulatory data and documentation within applicable systems.

• Represent Regulatory at internal and external project meetings, audits, CAPAs, proposal development activities, and bid defense meetings.

• Support the collection and maintenance of current global, regional, and country-specific regulatory intelligence.

• Contribute to process improvement initiatives, system reviews, and other activities supporting business success.

• Complete all required project-specific training.

• Travel up to 10% as required.

Job Responsibilities:

• Ensure regulatory deliverables are completed in accordance with applicable regulations, guidelines, policies, procedures, contractual timelines, and budgets.

• Lead the development and execution of global clinical trial submission strategies, including proactive risk identification and mitigation.

• Act as the primary client contact for assigned clinical trial regulatory deliverables.

• Prepare and maintain study-specific regulatory plans.

• Create, adapt, coordinate, review, and ensure compliance of global core regulatory documents.

• Track and report submission and approval progress in CTMS, eTMF, and other applicable systems.

• Perform quality control reviews of regulatory deliverables and ensure project teams remain informed of regulatory status.

• Coordinate clinical trial submissions and label review/approval activities in collaboration with stakeholders.

• Manage regulatory study budgets, contracted scope, forecasting, and identification of out-of-scope activities.

• Provide regulatory input during audits, CAPAs, proposals, and business development activities.

• Support regulatory consulting activities, as appropriate.

• Mentor junior team members and support cross-functional development where required.

• Participate in departmental and organizational initiatives as assigned.

• Perform other duties necessary to support the success of ICON’s business.

Job Requirements:

• BSc degree in a scientific field.

• 3–6 years of relevant global regulatory experience in pharmaceutical clinical trials.

• Strong knowledge of ICH, GCP, applicable regulations, and regulatory systems.

• Good communication, stakeholder management, and client-facing skills.

• Agile, adaptable mindset with strong organizational skills.

• Fluent written and spoken English.

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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.

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

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