Regulatory Operations Associate

Regulatory Operations Associate - Bulgaria - Home or office based but preference is for the person to work from our Warsaw office

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Job Description

• Provide support for submissions and other documents by performing necessary tasks including assembly, dispatch and coordinating resources for submissions to CTIS.

• Maintain submission components associated with a regulatory submission, as required.  This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking .

• Perform quality review of Regulatory Operations team members work to ensure accuracy.

• Participate in submission teams, maintaining necessary liaison between both project leader, and when applicable, with client.

• Responsible for managing project workflow throughout the submission process, including prioritizing project objectives, and overseeing progress of projects with other team members, ensuring timeframes and deadlines are met and identifying and relaying issues and resource needs when required.

• Maintain current knowledge of applicable regulations and industry best practices.  Participate in the interpretation of guidelines and impact assessment to current work procedures.  Anticipate Regulatory consequences and advise project teams on publishing issues and strategies.

• Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and government agencies in a polite and professional manner.

• Assist in the design and implementation of new processes or initiatives within the department.

• Participate in special projects and carry out assigned activities in support of the Publishing function.

To succeed you will need:

• Ideally you will have 1-2 years relevant experience within clinical research or have knowledge of clinical terminology and documentation
• Excellent communication skills and fluency in English
• Ability to work independently

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 to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply