Regulatory Affairs Specialist – ICON

Job Description

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 organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization 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.

Overview of the role:

Title: Regulatory Affairs Specialist

Location: Farmingdale NY (Can be on-site or remote)

Summary: The Duties of the Regulatory Affairs Specialist will depend on the nature of the projects to be undertaken. However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs. This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements, and may support business development activities.

Duties:
•Recognize, exemplify and adhere to ICON’s values which center around our commitment to People, Clients and Performance.
•Work closely with Supply Chain, Project Management, QA teams to identify process and procedure improvements and assist in implementation of continuous improvement measures to ensure dept expertise and to meet department goals.
•Identify issues and address them in a timely manner, including preventive actions. Be solution orientated and own the delivery and commitment on behalf of ICON.
•Keep abreast of regulatory procedures and changes to standards and Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements
•Initiate regulatory submission when required and support ICON team with Regulatory Inspections
•Effectively contribute to all the aspects of allocated projects in timely manner including, proactive identification of risks, scope change, regulatory implications for approval by VP/Directors.
•Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.
•Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.
•To be familiar with and to work in accordance with relevant ICON SOP’s and internal systems, GXP and appropriate regulations and guidelines.
•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 successful, you will need:
•Experience in regulatory requirements in clinical phase of biologics drug development is a plus
•FDA 510K, FDA QSR (3+ years experience)
•ISO 13485
•Excellent written and oral communication skills
•Good written and spoken English
•Strong technical writing and editing skills
•Travel (approximately 10-20%) domestic and/or international

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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