Senior Global Regulatory Scientist Drive Global Submissions

ICON Clinical Research; Warszawa; On-site; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement plan

LifeWorks

Life insurance

Flexible benefits

Job summary

ICON is seeking a Senior Global Regulatory Scientist in Poland to lead global regulatory strategies for clinical trials, ensure compliance with ICH-GCP, and coordinate submissions with regional authorities.

You will prepare core documentation, collaborate with cross-functional teams, and support audits and CAPAs. Travel about 10% is expected. A Bachelor's degree and 3 years of regulatory submission experience are required.

Qualifications

• Bachelor's degree and 3 years of regulatory submission experience.
• Strong understanding of ICH-GCP and global regulatory guidelines.
• Excellent organizational and communication skills with attention to detail.

Responsibilities

• 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.

Skills

Regulatory submissions

Global regulatory guidelines

Communication skills

Travel readiness

Education

Bachelor's degree

Job description

ICON is seeking a Senior Global Regulatory Scientist in Poland to lead global regulatory strategies for clinical trials, ensure compliance with ICH-GCP, and coordinate submissions with regional authorities.

You will prepare core documentation, collaborate with cross-functional teams, and support audits and CAPAs. Travel about 10% is expected. A Bachelor's degree and 3 years of regulatory submission experience are required.