Regulatory Affairs Assistant - 0.8 FTE

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
 

As a Regulatory Operations Assistant  you will provide comprehensive regulatory operations support(document level publishing and shipping activities) services for internal clients.

Main responsibilities:

• Responsible for coordinating all aspects of document level publishing for internal review and signoffs. 
• Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines
• Maintain submission components associated with a regulatory submission, paper and/or electronic, as required. This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking
• Assemble electronic PDF and paper Regulatory Submissions and packages for US Food and Drug Administration, the European Medicines Agency, Health Canada, and other international regulatory authorities
• Prepare shipping documentation
• 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.
• Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and clients.
• Assist in the design and implementation of new processes or initiatives within the department.

You are:

A quality focused self-starter with ambition to learn and develop.

To be successful as a Regulatory Operations Assistant within our Regulatory Affairs team, you must have excellent interpersonal, organisational and IT skills (Excel a must and MS Project a plus), attention to detail as well as the ability to multi task and integrate well into project teams.  Experience within the CRO / Pharma industry is not essential although this would be advantageous. Fluent written and spoken English is essential.

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

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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.