Global Regulatory Scientist/Senior Global Regulatory Scientist
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 Global Regulatory Scientist at ICON, you will prepare strategy and coordinate general clinical trial regulatory deliverables in compliance with ICON policies, applicable regulations, and ICH-GCP principles.
What You Will Do:
You will contribute to regulatory affairs activities, taking responsibility for your deliverables and working collaboratively.
Key responsibilities include:
- Develop and implement global clinical trial submission strategies and regulatory plans in collaboration with stakeholders.
- Prepare, review, and finalize core documentation and ensure compliance with regulatory requirements.
- Coordinate submissions to regulatory agencies, ethics committees,
and country-level authorities.
- Track and report submission progress in ICON systems, ensuring accuracy and completeness of documentation.
- Represent Regulatory during audits, CAPAs, and client meetings, providing strategic input and solutions.
Your Profile:
You will bring relevant regulatory affairs experience, along with the following qualifications and skills.
Required qualifications and experience:
- Bachelor's degree and 0-3 years of relevant regulatory submission experience.
- Strong understanding of ICH-GCP and general regulatory guidelines.
- Excellent organizational and communication skills with attention to detail.
- Willingness to travel as required (approximately 10%)
LI-TK1
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
📌 Global Regulatory Scientist (Madrid)
🏢 IRE
📍 Madrid
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