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