Regulatory Operations Associate

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Regulatory Operations Associate

Sofia, Bulgaria OR Warsaw, Poland

Hybrid role

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

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 through the form below.

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