Global Regulatory Scientist
On-siteWarsaw, Mazovia, Poland or Madrid, Madrid, Spain
Job Summary
Develop and implement global clinical trial submission strategies and regulatory plans in collaboration with stakeholders. Prepare, review, and finalize core documentation to ensure compliance with regulatory requirements, ICH-GCP principles, and ICON policies. Coordinate submissions to regulatory agencies, ethics committees, and country-level authorities while tracking progress in ICON systems. Represent Regulatory during audits, CAPAs, and client meetings, providing strategic input and solutions. Requires a Bachelor's degree, 0-3 years of relevant regulatory submission experience, and strong organizational skills. Approximately 10% travel required.
Required Qualifications
- Bachelor's degree
- 0-3 years of relevant regulatory submission experience
- Strong understanding of ICH-GCP and global regulatory guidelines
- Excellent organizational and communication skills with attention to detail
- Willingness to travel as required (approximately 10%)
- Legal right to work in the country where the role is based
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