Regulatory Affairs Specialist/Spécialiste affaires réglementaires-Canada
Core
Oversee Ethics Committee (EC) and Regulatory Authority (RA) submissions to ensure compliance with regulations and meet contractual 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
Dermatology / Clinical Research / Regulatory Affairs
Required skills
Knowledge of Health Canada, FDA, and EU regulations, GCP and ICH standards, Clinical Trial Application preparation, Ethics Committee submission management, Regulatory document review, Translation coordination
Preferred skills
French language proficiency (via careerplan.io/jobs/15-003-9A-279-regulatory-affairs-specialistspecialiste-affaires-reglementaires-canada)
Technologies
None stated
Responsibilities
Coordinate regulatory timelines and deadlines for RA and EC submissions, Review regulatory documents from subcontractors, Prepare CTA packages and submissions, 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 regional regulations, Participate in kick-off meetings and audits
Seniority
Mid-level, hands-on IC