Senior Associate, Quality Assurance & Regulatory Affairs

Adler Therapeutics Inc. is looking for a motivated and detail-oriented Senior Associate, Quality Assurance & Regulatory Affairs to join our growing team.

This role offers an opportunity to contribute to the establishment and ongoing development of our quality and regulatory resources while supporting the licensing of pharmaceutical products in Canada.

Working closely with leadership, manufacturers, and external partners, the Senior Associate will play an important role in coordinating regulatory activities, maintaining quality and compliance systems, and managing cross-functional projects.

• Support the development, implementation, and maintenance of quality management systems, SOPs, and internal processes.
• Coordinate regulatory licensing and registration activities for new pharmaceutical products in Canada.
• Support regulatory submissions, technical documentation, and ongoing regulatory maintenance.
• Coordinate quality assurance activities, vendor qualification, and compliance requirements with external partners.
• Monitor regulatory and project timelines, milestones, deliverables, and outstanding activities.
• Maintain quality records, regulatory documentation, agreements, and project trackers.
• Support operational planning, reporting, and continuous improvement initiatives.

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• Knowledge of pharmaceutical quality assurance, regulatory affairs, and Canadian regulatory requirements.
• Understanding of Health Canada's GMP, Medical Device Regulation, and quality management systems.
• Strong organizational, project coordination, and documentation skills.
• Proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint.
• Excellent communication skills and the ability to coordinate effectively with internal and external stakeholders.
• A proactive mindset, strong attention to detail, and the ability to manage multiple priorities.

Previous experience in pharmaceutical QA, regulatory affairs, or regulatory operations will be considered an asset.

At Adler Therapeutics, you’ll have the opportunity to work closely with leadership, contribute to building operational and quality systems, and take an active role in bringing pharmaceutical products to the Canadian market.

If you’re looking for a role that combines regulatory affairs, quality assurance, and project coordination, we’d like to hear from you.

Interested candidates can apply through LinkedIn or share their resume at [email protected].

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