Regulatory Affairs Specialist – Canada

This is a fully remote position, open to applicants in Canada.

📋 Description

• Manage the central Ethics Committee, Regulatory Authority, and other submissions to guarantee adherence to regulatory requirements and contractual deadlines.

• Provide direction for assigned projects and activities that lead to the initiation of clinical trials.

• Coordinate and monitor regulatory timelines and deadlines for respective Regulatory Authority and Ethics Committee submissions.

• Primarily oversee North American submissions, with potential involvement in EU and APAC submissions.

• Review regulatory documents and submissions created by subcontractors, partner CROs, and regulatory vendors.

• Prepare regulatory documents, Clinical Trial Application packages, and submissions for various countries.

• Prepare, manage, and keep track of Ethics Committee submissions.

• Act as the main contact for sponsors, subcontractors, and local teams concerning study regulatory submissions.

• Draft or evaluate Patient Information Sheets and Informed Consent Forms.

• Draft or evaluate study-specific regulatory forms.

• Manage translation requests with vendors.

• Offer regulatory support, guidance, submission strategies, and technical expertise to local project teams and both internal and external clients.

• Stay updated on Health Canada, FDA, and EU regulations.

• Participate in kick-off meetings, audits, and other project-related discussions.

⛳️ Requirements

• Bachelor's degree (or equivalent) in a scientific field.

• A minimum of 2-3 years of clinical research experience (in CRO or Pharma) with familiarity in Health Canada and FDA regulatory affairs and Ethics Committee regulations.

• Experience in the study start-up phase.

• Practical experience in preparing, reviewing, and submitting Clinical Trial Applications and Ethics Committee packages.

• Strong understanding of relevant regional/national regulatory guidelines and regulations.

• Excellent knowledge of GCP and ICH standards.

• Proficient in English with exceptional oral and written communication skills.

• Knowledge of additional languages, such as French, is a plus.

• Superior organizational and communication skills, with a keen attention to detail.

• Capable of organizing personal workload, prioritizing tasks, and working effectively under pressure.

• Ability to juggle multiple tasks simultaneously.

• Committed to meeting established deadlines, expectations, priorities, and objectives.

• Legally authorized to work in Canada.

🏝️ Benefits

• Flexible working hours.

• Permanent full-time position.

• Comprehensive benefits package: medical, dental, vision care, RRSPs, vacation, personal days, virtual medical clinic, and discounts on public transit, as well as social activities.

• Continuous training and development opportunities.

• Offices conveniently located near public transportation (Sherbrooke metro station or Saint-Laurent metro station).

• Attractive opportunities for advancement.