Senior Regulatory Affairs Specialist

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.
 

Summary:

The Senior Regulatory Affairs Associate has responsibility for providing comprehensive regulatory services to clients within the pharmaceutical, biologic, medical device or other regulatory services environments.  This will include support for assessment, registration, maintenance and other activities as assigned.

Job Description:

·       Recognize, exemplify, and adhere to ICON's values which center around our commitment to People, Clients, and Performance.

·       As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

·       To be familiar with and to work in accordance with relevant ICON SOP's and internal systems, GXP and appropriate regulations and guidelines.

·       Supports assigned teams in the preparation of all submission types in adherence with applicable legislation, regulations and guidelines facilitating approvals and continued client compliance.

·       Maintains a positive and productive liaison with internal and external contacts.  This may include clients, regulatory agencies, and related institutions.

·       Assists in the development of assessments and strategic regulatory plans for client product development programs.

·       Supports the development of initial or alternative strategies, consulting with their manager or other resources within the organization.  Assist in identification of project issues.

·       Responsible for supporting project workflow, including prioritizing project objectives for smaller projects and portions of larger projects, and establishing timeframes for projects with guidance from Manager/Director/senior team members.  

·       Responsible for overseeing progress and completion of their own projects and sub-projects ensuring timeframes and deadlines are met.

·       Supports submission approvals through effective communication with project team and client.

·       Reviews applicable client source documents to ensure they are consistent and editorially correct.

·       Support business operations by completing other appropriate duties as assigned by your people leader.

Requirements:

• Minimum 1-3 years of experience in a Global CRO / Big Pharma

• Relevant experience in Regulatory Affairs

• Excellent communication skills

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.

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