Regulatory Affairs Specialist/Spécialiste affaires réglementaires-Canada
Core
Overseeing Ethics Committee (EC) and Regulatory Authority (RA) submissions to ensure compliance with regulations and timelines for clinical trial start-up.
Role type
Regulatory Affairs Specialist (Clinical Research)
Builds
Clinical Trial Applications (CTA) and Ethics Committee packages for Health Canada, FDA, and EU
Domain
Clinical Research / Dermatology
Required skills
Regulatory document preparation, Ethics Committee submission management, Clinical Trial Application (CTA) preparation, Vendor management for translations, Regional regulatory guideline knowledge (Health Canada, FDA, EU), GCP and ICH standards knowledge
Preferred skills
French language proficiency (via careerplan.io/jobs/15-003-9A-279-regulatory-affairs-specialistspecialiste-affaires-reglementaires-canada-at-indero)
Technologies
None stated
Responsibilities
Coordinate regulatory timelines and deadlines for RA and EC submissions; Review regulatory documents created by subcontractors; Prepare and submit CTA packages and regulatory documents; Manage EC submissions; Act as point of contact for sponsors and local teams; Prepare or review Patient Information Sheets and Informed Consent forms; Manage translation requests; Provide regulatory support and advice to project teams; Maintain knowledge of Health Canada, FDA, and EU regulations; Participate in kick-off meetings and audits.
Seniority
Mid-level, hands-on IC