Regulatory Affairs Associate

il y a 2 semaines

Paris, France Icon plc Temps plein

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.

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. In France a clinical trial authorisation submission is made to Agence nationale de sécurité du médicament et des produits de santé (ANSM). 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.

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.
- 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
- Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations would be advantageous but is not essential.

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.

Are you a current ICON Employee? Please click here to apply:
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