Senior Regulatory Operations Associate

Senior Regulatory Ops Associate (Publishing)- Canada- Remote

ICON 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 development.

We are currently seeking a Senior Regulatory Operations Associate (Publishing) 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 innovative 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 publishing within the pharmaceutical, biotech or CRO industry.

• Proficiency in electronic document management systems (eTMF, eCTD) and regulatory submission software.

• Canadian submission background is preferred but not required.

• Strong understanding of regulatory requirements and guidelines for clinical trials.

• Excellent organizational, communication, and problem-solving skills.

Nous sommes actuellement à la recherche d’un(e) Associé(e) principal(e), Opérations réglementaires (publication) pour se joindre à notre équipe diversifiée et dynamique. À titre d’Associé(e) principal(e) des opérations réglementaires chez ICON, vous jouerez un rôle clé dans la gestion des documents et des processus réglementaires, contribuant ainsi à la réalisation réussie des essais cliniques et à l’avancement de traitements et de thérapies innovants.

Vos responsabilités

• Superviser la préparation, la compilation et la soumission des documents réglementaires pour les essais cliniques.

• Gérer les systèmes électroniques de gestion de documents (eTMF, eCTD) afin d’assurer la conformité et l’accessibilité des documents réglementaires.

• Fournir du soutien et des conseils aux parties prenantes internes concernant les processus des opérations réglementaires.

• Collaborer avec des équipes interfonctionnelles afin d’assurer la réalisation des livrables réglementaires dans les délais.

• Surveiller et optimiser en continu les processus des opérations réglementaires afin d’améliorer l’efficacité et la conformité.

Votre profil

• Baccalauréat dans un domaine scientifique ou connexe; diplôme d’études supérieures préféré.

• Minimum de 3 ans d’expérience en publication réglementaire dans l’industrie pharmaceutique, biotechnologique ou au sein d’une organisation de recherche sous contrat (CRO).

• Maîtrise des systèmes électroniques de gestion de documents (eTMF, eCTD) et des logiciels de soumission réglementaire.

• Une expérience des soumissions réglementaires canadiennes est un atout, mais non obligatoire.

• Bonne compréhension des exigences et des lignes directrices réglementaires applicables aux essais cliniques.

• Excellentes compétences en organisation, en communication et en résolution de problèmes.

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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 entitlements
• A 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site 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 here

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 here to apply