Job Purpose The Regulatory Affairs Associate is responsible for supporting new drug product registrations and maintaining current drug product registrations for our Canadian Brand Specialty portfolio. This role plays a pivotal part in ensuring regulatory compliance, timely submissions, and successful approvals from Health Canada.

Duties And Responsibilities

• Assist with planning, preparing, coordinating, compiling, reviewing and submitting regulatory dossiers (e.g., NDS, SNDS, NC, Level III Changes) to Health Canada
• Prepare responses to Health Canada clarification requests in a timely manner throughout the submission lifecycle
• Maintain current drug product registrations and support post-approval regulatory activities
• Review product packaging, labeling, and promotional materials for compliance
• Review change controls and assess impact of regulatory updates and support implementation of necessary changes
• Track submission milestones and post-approval commitments
• Support product launch activities from a regulatory perspective
• Support regulatory strategy development for new product filings and lifecycle management
• Monitor and interpret changes in Canadian regulatory guidance
• Maintain accurate and organized regulatory documentation
• Work closely with departments including Quality, R&D, Marketing, and Supply Chain
• Other regulatory responsibilities as required by the Director

Additional Responsibility (Only Applicable To Customer Facing Roles)

• Report any adverse event received from customers for company products to the pharmacovigilance/drug safety department within 1 business day

Qualifications Knowledge, Skills and Abilities:

• Familiarity with Health Canada regulatory guidelines and submission processes (including chemistry and manufacturing, labeling and format requirements)
• Ability to interpret regulations and create compliant documentation
• Strong interpersonal, written and verbal communication skills
• Excellent organizational and time-management abilities to adhere to submission timelines
• Comfortable working on multiple priorities and deadlines
• High attention to detail and accuracy
• Collaborative and adaptable in fast-paced environments
• Proactive problem-solving mindset with a focus on compliance and quality
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat and document management systems
• Knowledge of GMP requirements and QA/QC procedures

Background And Experience

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field
• Postgraduate studies or certification in Regulatory Affairs (e.g., RAPS, TOPRA) is an asset
• 3 or greater years of drug or drug/device regulatory affairs experience within the pharmaceutical or healthcare industry

Working conditions

• Local Canadian office
• Extensive use of computer
• Varied work schedule to meet deadlines, as required

Physical Requirements

• Hybrid role (in office at least 3 days a week)

Direct reports NA