Job purposeThe 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
QualificationsKnowledge, 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
