Opportunité de Carrière : Senior Regulatory Operations Associate chez ICON
Description Générale
Entreprise : ICON est une organisation mondiale reconnue pour son expertise en intelligence de la santé et en recherche clinique. Cet emploi à distance est ouvert pour les candidats basés au Brésil et au Mexique. ICON s’engage à créer un environnement inclusif qui favorise l’innovation et l’excellence.
Poste : Senior Regulatory Operations Associate
Type de contrat : CDD (Fixed Term Position)
Localisation : São Paulo – SP
Date de publication : Mercredi, 02 juillet 2025
Responsabilités
Le rôle de Senior Regulatory Operations Associate est central dans la gestion des documents et des processus réglementaires, contribuant ainsi à la réussite des essais cliniques et à l’évolution de traitements innovants. Voici les principales missions :
- Préparation et soumission : Superviser la préparation, la compilation et la soumission des documents réglementaires pour les essais cliniques.
- Gestion des systèmes électroniques : Gérer les systèmes de gestion documentaire électroniques (eTMF, eCTD) pour garantir la conformité et l’accessibilité des documents réglementaires.
- Support interne : Fournir support et conseils sur les processus des opérations réglementaires aux parties prenantes internes.
- Collaboration inter-équipes : Travailler avec des équipes interfonctionnelles pour garantir l’achèvement en temps voulu des livrables réglementaires.
- Optimisation continue : Surveiller et optimiser en continu les processus d’opérations réglementaires pour améliorer efficacité et conformité.
Profil Recherché
Pour le poste, ICON recherche des candidats possédant les qualifications suivantes :
- Formation : Diplôme de Bachelor dans un domaine scientifique ou similaire ; un diplôme avancé est préféré.
- Expérience : Minimum de 3 ans d’expérience dans les opérations réglementaires au sein de l’industrie pharmaceutique ou biotechnologique.
- Compétences techniques : Maîtrise des systèmes de gestion documentaire électronique (eTMF, eCTD) et des logiciels de soumission réglementaire.
- Connaissance des exigences : Solide compréhension des exigences et directives réglementaires pour les essais cliniques.
- Compétences essentielles : Excellentes compétences en organisation, communication et résolution de problèmes.
Pourquoi Rejoindre ICON ?
ICON se distingue par sa culture de haute performance et sa valorisation des talents. Voici quelques avantages attrayants que l’entreprise offre :
- Salaire compétitif : Des salaires régulièrement évalués par rapport à la concurrence, avec des primes annuelles basées sur l’atteinte des objectifs de performance.
- Bénéfices sur la santé : Une gamme de prestations de santé pour les employés et leurs familles, avec des plans de retraite compétitifs.
- Sens du but : Un environnement dynamique où chaque employé est encouragé à réaliser son potentiel et à contribuer à un changement positif dans l’industrie.
Engagement envers l’Inclusion
ICON s’engage à être un employeur égalitaire et inclusif, garantissant un environnement sans discrimination ni harcèlement. L’ensemble des candidatures sera examiné de manière équitable, indépendamment de la race, de la couleur, de la religion, du sexe ou d’autres critères protégés.
Comment Postuler
Les candidats intéressés sont encouragés à postuler, même s’ils ne répondent pas à tous les critères. Pour ceux qui ont des besoins d’adaptation en raison d’un handicap, ICON invite à soumettre une demande de soutien.
Postulez dès maintenant !
En somme, cette annonce pour le poste de Senior Regulatory Operations Associate chez ICON illustre un engagement fort envers la qualité, la diversité, et l’inclusion dans le domaine de la recherche clinique. Les candidats motivés, partageant cette vision, sont invités à se manifester.
📅 Date de publication de l’offre : Wed, 02 Jul 2025 06:39:33 GMT
🏢 Entreprise : ICON
📍 Lieu : São Paulo – SP
💼 Intitulé du poste : Senior Regulatory Operations Associate – Fixed Term Position
💶 Rémunération proposée :
📝 Description du poste : Senior Regulatory Operations Associate – Remote – Brazil and MexicoICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentAt 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.We are currently seeking a Senior Regulatory Operations Associate to join our diverse and dynamic team. As a Senior Regulatory Operations Associate at ICON, you will play a pivotal role in managing regulatory documents and processes, contributing to the successful execution of clinical trials and the advancement of inNvative treatments and therapies.What you will be doing
- Overseeing the preparation, compilation, and submission of regulatory documents for clinical trials.
- Managing electronic document management systems (eTMF, eCTD) to ensure compliance and accessibility of regulatory documents.
- Providing support and guidance on regulatory operations processes to internal stakeholders.
- Collaborating with cross-functional teams to ensure timely completion of regulatory deliverables.
- Continuously monitoring and optimizing regulatory operations processes to improve efficiency and compliance.
Your profile
- Bachelor’s degree in a scientific or related field; advanced degree preferred.
- Minimum of 3 years of experience in regulatory operations within the pharmaceutical or biotech industry.
- Proficiency in electronic document management systems (eTMF, eCTD) and regulatory submission software.
- Strong understanding of regulatory requirements and guidelines for clinical trials.
- Excellent organizational, communication, and problem-solving skills.
#LI-Remote#LI-AR2Benefits 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.What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:Various annual leave entitlementsA range of health insurance offerings to suit you and your family’s needs.Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.Life assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.Visit our to read more about the benefits ICON offers.At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request .Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.Are you a current ICON Employee? Please click to apply
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