Lead regulatory operations and strategy as a Regulatory Affairs Manager with a focus on Health Canada at an established pharmaceutical manufacturer in Mississauga. This senior role demands strategic thinking and precision in managing the regulatory lifecycle.
In this senior leadership role, you will spearhead Health Canada submission strategies and oversee regulatory operations for a diverse product portfolio. With over eight years of pharmaceutical regulatory experience essential, you will guide Health Canada submissions from filing to approval, mentor a regulatory team, and collaborate cross-functionally with various departments, including Quality and Manufacturing.
Key Responsibilities:
• Manage Health Canada submission preparation and lifecycle
• Define and execute filing strategies for successful submissions
• Navigate deficiency management and agency interactions
• Conduct dossier gap assessments and review DMFs
• Oversee external consultants and regulatory vendors
Requirements:
• Minimum eight years of Regulatory Affairs experience
• Five years with direct Health Canada submission experience
• Proven track record managing multiple submissions
• Expertise in deficiency responses and agency negotiations
• Robust knowledge of eCTD publishing systems
Drive the regulatory vision for product success within the pharmaceutical industry in Mississauga.
#J-18808-Ljbffr