# Senior Global Regulatory Scientist

**Company**: ICON
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

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## Description

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.

Responsibilities:

- 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.

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 organisational skills.

- Fluent written and spoken English.

Rewards & Benefits:

- 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

## Skills

### Required
- ICH
- GCP
- regulatory systems
- communication
- stakeholder management
- organisational skills

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