Director, Regulatory Affairs - Regulatory Intelligence

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.

Director, Regulatory Affairs

Location- US (remote)

The Director, Regulatory Affairs within ICON Laboratory & Imaging Solutions (ILI) will identify, assess, and mitigate regulatory risk, across a network of laboratories supporting clinical trials conducted across dozens of countries around the world.

The Director, Regulatory Affairs, ILI will actively monitor the evolving regulatory environment for laboratory testing in support of clinical trials, with a primary focus on US and EU, but including more than 30 other countries where trials supported by ILI are active. Incumbent will collaborate closely with managers and executives across ILI to evaluate regulatory compliance gaps and risks, and to devise and implement new business practices in order to maintain a high standard or regulatory compliance. This person will engage subject matter experts from within and from outside ICON as needed to gather necessary insight regarding different regulatory topics or their application to different regulatory jurisdictions, as needed, and will synthesize this information to inform risk assessments and risk management actions. Reporting to the Vice President, Medical Affairs, ILI, the Director will serve as an important partner for the Senior Leadership Team of ILI in the prompt and effective management of regulatory issues.

The Director, Regulatory Affairs will also lead, coordinate, or support as needed the delivery of billable regulatory affairs services to research sponsors supported by ILI, for example, in the preparation and submission of regulatory paperwork associated with the conduct of Study Risk Determinations and applications for Investigation Device Exemptions before the US FDA and equivalent activities before competent authorities in other jurisdictions. The incumbent will, where possible, provide some of these service directly, or will identify and collaborate with regulatory professionals residing with other parts of ICON to support this billable work on behalf of research sponsors. This person will serve as the primary point of contact within ILI for these other regulatory groups, and as appropriate with Legal Affairs regarding issues which are regulatory in nature.

Candidate Requirements:

• Minimum of 5 years of work experience with responsibilities in Regulatory Affairs in relation to in vitro diagnostics (IVD) or medical devices

• Prior experience working with global clinical trials

• Progressive experience service as regulatory liaison in US and/or EU regulatory environment; other jurisdictions desirable

• Direct experience with regulatory agency meetings and negotiations

• Minimum BSc/BA in relevant scientific field (e.g. Biology, Pharmacy, Chemistry); higher degree in relevant discipline desirable

• Ability to evaluate and synthesize complex information and communicate effectively at executive level

• Ability to collaborate effectively with experts within and outside of ICON to accomplish objectives

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.

Visit our careers site to read more about the benefits ICON offers.

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