Regulatory Affairs Specialist – Canada

About Freyr Freyr is a global Regulatory Solutions and Services company supporting the life sciences industry across the entire product lifecycle. With deep regulatory expertise and a global presence, Freyr partners with pharmaceutical, biotechnology, medical device, and consumer healthcare companies to accelerate product approvals and maintain regulatory compliance worldwide. Job Title: Regulatory Affairs Specialist – Canada Location: Toronto, ON - Remote Employment Type: Full-Time Role Overview Freyr is seeking a detail-oriented Regulatory Affairs Specialist to support regulatory operations for pharmaceutical products in Canada. This role will be responsible for preparing, reviewing, coordinating, and maintaining regulatory submissions in compliance with Health Canada requirements while collaborating with global, regional, and local cross-functional teams to ensure timely, high-quality regulatory deliverables. Key Responsibilities Regulatory Submission Management Prepare, compile, review, and submit regulatory dossiers to Health Canada. Manage Module 1 administrative documentation for various submission types. Prepare and support submissions including: SNDS (Labelling Only) SNDS (Safety) CCDS implementation updates Risk Management Plan (RMP) updates Foreign Safety Notifications Level III (Non-CMC) submissions Clinical Trial Applications (CTA) and CTA Amendments Coordinate responses to Health Canada information requests and regulatory queries. Ensure submissions are completed accurately and within regulatory timelines. Labeling & Lifecycle Management Support implementation of global CCDS updates into Canadian product labeling. Perform label reviews and redline comparisons. Prepare labeling documentation for regulatory submissions. Track implementation timelines and regulatory commitments. Regulatory Intelligence & Compliance Monitor Health Canada regulations, guidance documents, and policy updates. Conduct Health Canada Release Assessments and communicate regulatory impacts. Support regulatory compliance and regulatory assessment activities. Maintain submission trackers, regulatory databases, and submission records. Cross-Functional Collaboration Partner with Global Regulatory Affairs, Clinical, Safety, Quality, and Supply Chain teams. Coordinate document collection and submission planning activities. Participate in project planning, timeline management, and regulatory strategy discussions. Contribute to knowledge sharing and continuous process improvement initiatives. Documentation & Quality Ensure all regulatory documents meet company quality standards and Health Canada requirements. Maintain inspection-ready regulatory records and submission archives. Support SOP compliance and document management activities. Qualifications & Experience Education Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biology, or a related scientific discipline. Master's degree is an asset. Required Experience 5+ years of Regulatory Affairs experience within the pharmaceutical industry. Hands-on experience preparing and managing Health Canada regulatory submissions. Strong knowledge of Canadian regulatory requirements and submission processes. Experience with: SNDS CTA/CTA Amendments CCDS implementation RMP updates Foreign Safety Notifications Labeling submissions Experience coordinating cross-functional regulatory activities. Strong understanding of product lifecycle management and post-approval regulatory maintenance. Preferred Skills In-depth knowledge of Health Canada regulations and guidance. Strong attention to detail and document quality. Excellent written and verbal communication skills. Strong organizational and project management abilities. Experience working in a global regulatory environment. Ability to manage multiple submissions and competing priorities. What We Offer Competitive compensation and comprehensive benefits package. Opportunity to work on global regulatory projects. Collaborative and inclusive work environment. Career growth within a global regulatory organization. Exposure to diverse pharmaceutical products and regulatory pathways. Why Join Freyr? At Freyr, you'll work alongside experienced regulatory professionals supporting innovative pharmaceutical products across global markets. This role offers the opportunity to contribute to critical Health Canada submissions while building expertise within a collaborative, high-performing regulatory team.

The role involves preparing and managing regulatory dossiers and submissions to Health Canada to ensure pharmaceutical product compliance. It also includes managing product labeling, monitoring regulatory intelligence, and collaborating with cross-functional global teams.

Candidates must have a Bachelor's degree in a scientific discipline and over 5 years of pharmaceutical regulatory affairs experience. Proven expertise in Health Canada submission processes and product lifecycle management is required.

• Competitive Compensation • Comprehensive Benefits Package • Career Growth Opportunities

• Gestion de projetSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Regulatory Submissions
• Health Canada Compliance
• Dossier Preparation
• Labeling Management
• Regulatory Intelligence
• Product Lifecycle Management
• Cross-functional Collaboration
• Project Management
• SNDS
• CTA Amendments
• CCDS Implementation
• RMP Updates
• Foreign Safety Notifications
• Document Quality Control
• Regulatory Strategy
• Risk Management

• Healthcare
• Science & Research
• Consulting
• Manufacturing
• Legal

Formation minimale

Baccalauréat

Expérience minimale

5+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Associate

Mode de candidature

La candidature directe est offerte