- Oversee central Ethics Committee, Regulatory Authority, and other submissions to ensure regulatory compliance and contractual timelines
- Provide leadership for assigned projects and activities leading to clinical trial start-up
- Coordinate regulatory timelines and deadlines for assigned Regulatory Authority and Ethics Committee submissions
- Oversee mainly North American submissions, with possible participation in EU and APAC submissions
- Review regulatory documents and submissions prepared by subcontractors, partner CROs, and regulatory vendors
- Prepare regulatory documents, Clinical Trial Application packages, and country submissions
- Prepare, manage, and track Ethics Committee submissions
- Serve as point of contact for sponsors, subcontractors, and local teams regarding study regulatory submissions
- Prepare or review Patient Information Sheets and Informed Consent Forms
- Prepare or review study-specific regulatory forms
- Manage translation requests with vendors
- Provide regulatory support, advice, submission strategies, and technical expertise to local project teams and internal/external customers
- Maintain knowledge of Health Canada, FDA, and EU regulations
- Participate in kick-off meetings, audits, and other project-related meetings
Requirements
- Bachelor's degree (or equivalent) in a scientific discipline
- Minimum of 2-3 years of clinical research experience (in CRO or Pharma) working within Health Canada and FDA regulatory affairs and with Ethics Committee regulations
- Experience in study start-up phase
- Hands-on experience preparing, reviewing, and submitting Clinical Trial Applications and Ethics Committee packages
- Excellent knowledge of applicable regional/national regulatory guidelines and regulations
- Excellent knowledge of GCP and ICH standards
- Fluency in English with excellent oral and written skills
- Additional languages, such as French, are an asset
- Excellent organization and communication skills and attention to detail
- Ability to organize own work, prioritize assignments, and work under pressure
- Ability to multitask
- Ability to respect established timelines, expectations, priorities, and objectives
- Legally authorized to work in Canada
Core Competencies
Demonstrates expertise in regulatory compliance and clinical trial management, with a strong focus on Health Canada and FDA regulations. Proficient in preparing and reviewing Clinical Trial Applications and Ethics Committee submissions while ensuring adherence to GCP and ICH standards.
Highest-signal resume keywords
- Regulatory Compliance
- Clinical Trial Application Preparation
- Ethics Committee Submission Management
- Knowledge of GCP and ICH Standards
- Fluency in English
ATS Optimization Keywords
Hard Skills
- Clinical Research Experience
- Regulatory Document Review
- Clinical Trial Application
- Ethics Committee Regulations
- Regulatory Submission Strategies
- Patient Information Sheets Preparation
- Informed Consent Forms Review
- Study Start-Up Phase Experience
- Regulatory Guidelines Knowledge
- Multitasking
Soft Skills
- Excellent Communication Skills
- Attention to Detail
- Organizational Skills
- Ability to Work Under Pressure
- Prioritization Skills
Industry Keywords
- Health Canada
- FDA
- EU Regulations
- CRO
- Pharma
- GCP
- ICH
- Regulatory Authority
- Clinical Trial Management
- Ethics Committee
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Regulatory Affairs Specialist – Canada Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
