Regulatory Affairs Specialist

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

With our patients at the center 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.

The role:
• As member of the Regulatory Submissions team, you will contribute to at least one of the following activities:
• Preparation, compilation and submission of CT /IND, MAA I NOA. Variations/ lifecycle submissions, DSUR, PSUR, renewals, agency briefing documentation
• Management and Implementation of label review, translation requirements, fee requirements etc. for regulatory submissions
• Input to the Reg Intel function
• Readability testing
• IMPD / IB Core Doc review, labelling review for CT
• May work either as part of Regulatory Submissions team or as part of a regulatory or cross-functional team depending on the size and nature of project
• May support business development activities

Responsibilities:
• Responsible for providing advice and support to the project team for regulatory operations aspects of the projects.
• Manage and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.)
• Maintain a strong customer service management approach with clients.
• Lead project teams and advise departments on regulatory standards issues and strategies
• Develop, write, and implement standards and procedures related to regulatory operations.
• Identify client issues and develop alternative strategies for presentation to client consulting with other resources within organization as required
• Participate actively in other business related projects (business opportunities, client specific issues, etc.) and planning.
• Client consultation and preparation of quotes and is responsible for achieving utilization goals of the EU unit.
• Completing other appropriate duties as assigned by line manager that require similar skills

You will need:
• Experience in eCTD, NeeS, Paper Submissions.
• Experience in EU, US and Canada HA submissions.
• Experience in Lorenz Docubridge and ISI Tool Box
• Experience in sequence building and document level publishing
• Good knowledge on the CTD sections.

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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