Regulatory Affairs Associate

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre 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:

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:

• 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).

• 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

• Be the powerhouse accountable for all the country-level approvals. In BE/NL a clinical trial authorisation submission is made to the “Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten” (FAGG) for Belgium and to the “College ter Beoordeling van Geneesmiddelen” (CBG).

• Being responsible for preparing this submission, working through the assessment process to the successful approval from the FAGG and/or CBG

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 languages, such as Dutch (and French)

• 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!

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.

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