Deliver all regulatory submission activities in line with study requirements, ICON procedures, applicable regulations and contractual timelines.
Prepare, adapt, coordinate and collate high-quality submission documentation for Regulatory Agencies (RA), Central Ethics Committees (CEC) and other authorities.
Contribute to submission strategy planning, including proactive risk identification and mitigation.
Interact directly with regulatory and ethics bodies as required.
Manage the end-to-end lifecycle of submissions through to approval.
Track submission progress and maintain complete, accurate records in CTMS, eTMF and other relevant systems.
Coordinate translation requirements in accordance with project needs.
Flag out-of-scope work and support budget adherence.
Keep project teams informed of all relevant regulatory milestones and approvals.
Collaborate with regional and global colleagues to meet study deliverables.
Support the collection and maintenance of global/regional/country regulatory intelligence.
Contribute to process improvement initiatives that streamline ways of working and add value.
Mentor junior team members and participate in system/procedure reviews, depending on experience.
Complete all study-specific training on time and uphold ICON’s quality and compliance standards.
Take on any additional responsibilities needed to support ICON’s success.

Minimum 3 years of relevant regulatory experience in a CRO or pharmaceutical company.
Strong working knowledge of ICH-GCP, regional regulatory requirements, ethics committee processes and clinical trial legislation.
Excellent organisational skills with a knack for managing competing priorities.
A proactive, solutions-focused approach with a continuous improvement mindset.
Strong communication and stakeholder-engagement skills.
A genuine commitment to delivering high-quality work and supporting team success.

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.

Senior Regulatory Submission Specialist

Key skills