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.
 

The Role

ICON Biotech Solutions Global Regulatory Clinical Services (GRCS) team helps ICON’s clients navigate the intricate regulatory agency and ethics committee approval and life cycle challenges.

As a Regulatory Affairs Associate at ICON Biotech Solutions you would fulfil the Local Regulatory Affairs Associate (LRAL) role. The LRALs provide “on-the-ground” support for gaining clinical trial authorisation from all country-level authorizing bodies including the Regulatory Agency and Central Ethics Committee (CECs). The LRALs prepare submissions according to requirements in the local language and facilitate the assessment–including rapid responses–to questions based on their understanding of current country expectations and rate-limiting factor.

Local regulatory affairs associates (LRALs) are the powerhouses accountable for all the country-level approvals. The LRAL would be responsible for preparing this submission, working through the assessment process to the successful approval from ANSM.

GRCS have a thriving team culture which is at the heart of its success and the leadership team are committed to developing continuous learning opportunities for all where we challenge you with engaging work and where your experience adds to your professional development.

You are:

To be successful in this role you need to be an effective communicator, have strong organizational skills, a willingness to learn and be able to approach problems with a creative and collaborative mindset.

We are seeking candidates with,

• An undergraduate degree ideally in science, or health-related field.
• The ability to absorb new information and have a passion for learning
• Strong communication skills and fluency in written and spoken English and local language
• Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations would be advantageous but is not essential.

We welcome applications from those wanting to take the first step in a career within Regulatory Affairs!

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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