Hybrid Manager, Regulatory Operations – eCTD Operations

at ICON plc

• Job title: Manager, Regulatory Operations – eCTD Operations
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Burlington, Canada

About the role

• Manager of Regulatory Operations overseeing eCTD submissions and leading project teams offering regulatory guidance. Responsible for compliance, training, and maintaining stakeholder relationships in healthcare research.

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

Requirements

• 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.

Benefits

• 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, 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 assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.