Manager, Regulatory Operations - eCTD Operations

Manager, Regulatory Operations (CTIS)

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.

Job Title: Manager Regulatory Operations - eCTD Operations

Location: Hybrid in Burlington or Remote  

Responsibilities:

• Lead the Regulatory Operations project team, providing guidance on regulatory standards, advising on strategies, delivering training, recruitment, workforce planning, and personal development
• Manage eCTD submissions, ensuring they are tracked accurately and in full compliance with regulatory guidelines
• Participate in development of internal processes for eCTD
• Recruitment and training of regulatory personnel for eCTD submissions
• Oversee the global publishing, compilation, filing, and maintenance of regulatory submissions
• Maintain positive and productive relationships with internal and external stakeholders, including regulatory agencies, clients, colleagues, and staff
• Coordinate with country-specific regulatory affairs personnel to support international submissions and registrations
• Engage with regulatory agencies and standards development bodies (such as ICH, CDISC, and HL7) to stay informed about new developments in electronic regulatory standards
• Lead the implementation of new regulatory standards, processes, and SOPs within the department

You Are:

• Bachelor's degree or equivalent experience in a relevant field
• Proven experience working with eCTD submissions
• Demonstrated ability to produce high-quality work with strong attention to detail
• Experienced in creating and delivering effective training materials
• Strong leadership skills with the ability to support and guide team members with both compassion and confidence

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Titre du poste : Manager des Opérations Réglementaires – Opérations eCTD

Lieu : Hybride à Burlington ou Télétravail

Responsabilités :

• Diriger l’équipe de projets des Opérations Réglementaires, en fournissant des conseils sur les normes réglementaires, en définissant des stratégies, en assurant la formation, le recrutement, la planification des effectifs et le développement professionnel.

• Gérer les soumissions eCTD, en veillant à leur suivi précis et à leur conformité totale aux directives réglementaires.

• Participer à l’élaboration et à l’amélioration des processus internes relatifs à l’eCTD.

• Recruter et former le personnel réglementaire chargé des soumissions eCTD.

• Superviser la publication, la compilation, le dépôt et la maintenance des soumissions réglementaires à l’échelle mondiale.

• Maintenir des relations positives et productives avec les parties prenantes internes et externes, y compris les agences réglementaires, les clients, les collègues et les collaborateurs.

• Coordonner avec les équipes réglementaires locales pour soutenir les soumissions et enregistrements internationaux.

• Collaborer avec les agences réglementaires et les organismes d’élaboration de normes (tels que l’ICH, le CDISC et le HL7) afin de rester informé des nouvelles évolutions en matière de normes réglementaires électroniques.

• Piloter la mise en œuvre de nouvelles normes, procédures et processus réglementaires au sein du département.

Profil recherché :

• Diplôme universitaire (ou expérience équivalente) dans un domaine pertinent.

• Expérience avérée dans la gestion des soumissions eCTD.

• Excellente capacité à produire un travail de haute qualité avec une grande attention aux détails.

• Expérience dans la conception et la mise en œuvre de supports de formation efficaces.

• Solides compétences en leadership, avec la capacité d’accompagner et de motiver les membres de l’équipe avec bienveillance et assurance.

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#LI-Remote

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