Senior Associate, Regulatory Affairs 12- Months Fixed Term Contract (Toronto, Ontario)

Job Description

Senior Associate, Regulatory Affairs – 12-month Fixed Term Contract, Toronto, Ontario, Canada. Supports regulatory activities to obtain and maintain drug product registration status in compliance with Canadian drug laws and corporate policies. Acts as subject matter authority for Regulatory Affairs delivering guidance to local and global business partners.

Responsibilities

• Develop and implement regulatory strategic plans for product registration and lifecycle management.
• Manage preparation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and ad hoc reports to Health Canada, and maintain the life cycle of currently marketed products.
• Manage development and review of responses to Health Canada queries (e.g., Clarifax, Notice of Non-Compliance, Notice of Deficiency) in a timely manner.
• Lead in partnership with Director of Regulatory Affairs inte...