Regulatory Affairs Specialist – Canada

Stellenbeschreibung:

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.