Title:  Associate, Regulatory Affairs

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