Senior global Regulatory Scientist

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

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 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.

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 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%)

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)