What You'll Do
Oversee the development and submission of regulatory dossiers required to launch clinical trials, including clinical trial applications and ethics committee packages. Serve as a central point of contact for securing authorizations from regulatory bodies and institutional review boards. Maintain accurate, up-to-date records of all submissions, approvals, and communications throughout the start-up phase.
Provide regulatory guidance to project teams, helping ensure study start-up activities align with applicable standards and timelines. Collaborate with internal departments and external partners to resolve queries and accelerate approval processes. Contribute to continuous improvement by identifying inefficiencies and supporting the implementation of optimized workflows in study start-up operations.
Requirements
- Hold a bachelor’s degree in life sciences or a closely related discipline
- Have at least two years of hands-on experience in clinical research or regulatory affairs, with a focus on study start-up processes
- Demonstrate solid knowledge of ICH-GCP guidelines and regional regulatory requirements for clinical trials
- Possess strong organizational abilities, with proven capacity to manage multiple deadlines and shifting priorities
- Communicate clearly and effectively across diverse teams, both internally and externally
Benefits
You will receive a competitive base salary and access to a comprehensive benefits package tailored to support your personal and professional well-being. This includes multiple health insurance options, retirement planning programs designed to enhance long-term financial security, and life assurance coverage.
Additional offerings include generous annual leave policies and access to TELUS Health’s global Employee Assistance Programme, providing 24/7 support for mental and physical health needs. Depending on your location, you may also choose from flexible benefits such as subsidized gym memberships, childcare vouchers, commuter passes, bicycle purchase schemes, and preventive health assessments.
Company Culture
Work in an environment committed to inclusion, where diverse perspectives are valued and contribute to operational excellence. The organization promotes equitable treatment for all employees and fosters a workplace free from discrimination and harassment. Sustainability and community engagement are integrated into business practices, reflecting a broader commitment to responsible growth and social impact.
