Compliance Director safeguarding Zodia Custody against financial crime under Luxembourg regulations. Ensuring a robust compliance framework and managing regulatory requirements.
About the role
- 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.
Job title
Job type
Experience level
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Not specified
Degree requirement
Location requirements
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