Senior Regulatory Publishing Associate
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Job Description
Senior Regulatory Ops Associate overseeing regulatory document management for clinical trials at ICON healthcare intelligence. Collaborating cross-functionally to optimize regulatory processes for innovative therapies.
Responsibilities:
- Oversee the preparation, compilation, and submission of regulatory documents for clinical trials.
- Manage electronic document management systems (eTMF, eCTD) to ensure regulatory compliance and accessibility of documents.
- Provide support and guidance on regulatory operations processes to internal stakeholders.
- Collaborate with cross-functional teams to ensure timely completion of regulatory deliverables.
- Continuously monitor and optimize 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 with electronic document management systems (eTMF, eCTD) and regulatory submission software.
- Canadian submission experience 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 options to suit you and your family’s needs.
- Competitive retirement planning options to help maximize savings and plan with confidence for the future.
- Global Employee Assistance Programme (TELUS Health), offering 24-hour access to a global network of over 80,000 independent specialised professionals 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, and more.
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