Apply on Kit Job: kitjob.ca/job/2fs7xb

Join the forefront of biopharma as a Regulatory Affairs Project Leader in CMC. Drive regulatory strategies and submissions to ensure effective compliance and rapid market access.
This role requires you to manage all CMC regulatory activities for drugs and biologics. Collaborating with cross-functional teams and ensuring compliance with Health Canada and ICH guidelines will be your primary focus. Your ability to navigate complex regulatory frameworks will be instrumental in driving successful submissions and fostering strong stakeholder relationships.
Key Responsibilities:
• Lead regulatory CMC activities for drug submissions
• Collaborate with internal teams and external partners
• Prepare pre-submission documents and respond to inquiries




• Maintain compliance with CMC regulatory standards
• Assess new business opportunities for regulatory impacts
Requirements:
• 2-5 years of pharmaceutical regulatory experience
• Knowledge of CMC regulations and drug development
• Required: BSc or a related health degree
• Solid submission leadership capabilities
• Fluent in English; French proficiency is advantageous
Harness your expertise in regulatory affairs and make impactful contributions to the future of healthcare innovation.
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Apply on Kit Job: kitjob.ca/job/2fs7xb

📌 Dynamic Regulatory Project Leader in Chemistry Manufacturing Controls (Toronto)
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