Regulatory Scientist / Senior Regulatory Scientist / Sofia / Warsaw
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 support the development, implementation, and execution of regulatory strategies for clinical development programmes.
What You Will Do:
You will take responsibility for regulatory affairs deliverables, applying your skills to ensure quality and efficiency.
Key responsibilities include:
Contributing to regulatory strategy development for clinical programmes, including plans for health authority interactions and submissions.
Preparing, reviewing, and coordinating regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions.
Interpreting and applying relevant regulations, guidelines, and precedents to support compliant study design and execution.
Collaborating with clinical, safety, CMC, and other cross-functional teams to ensure alignment of regulatory content and messaging.
Monitoring changes in the regulatory environment and providing guidance on potential impact to programmes and submissions.
Supporting regulatory interactions and meetings, including preparation of materials and documentation of outcomes.
Your Profile:
You will bring relevant regulatory affairs experience, along with the following qualifications and skills.
Required qualifications and experience:
Bachelor's degree in a relevant scientific discipline or healthcare-related field
Experience in regulatory affairs, regulatory writing, or clinical development within the pharma, biotech, or CRO industry.
Good understanding of global regulatory frameworks and guidelines relevant to clinical development.
Strong scientific, analytical, and critical thinking skills, with the ability to interpret complex data and regulations.
Excellent written and verbal communication skills, with high attention to detail and accuracy.
Ability to work effectively in cross-functional teams and manage multiple regulatory activities and timelines.
Willingness to travel as required (approximately 5%)
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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 your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here
Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
