Senior 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:

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.

Responsibilities:
* Recognize, exemplify and adhere to ICON's values which centre 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.

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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