Senior Regulatory Operations Associate overseeing regulatory documents for clinical trials at ICON plc. Collaborating with teams to ensure compliance and optimize processes in pharmaceutical research.
Responsibilities
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.
Requirements
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.
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.
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