Regulatory Affairs Manager

Location: Scarborough, Ontario (Toronto, Canada) – Hybrid: 3 days on-site.

Responsibilities

• Lead preparation, submission, and maintenance of Abbreviated New Drug Submissions (ANDS), Supplemental Abbreviated NDSs (sANDS), and other regulatory filings to Health Canada.
• Ensure timely updates to product labeling materials, including safety updates to product monographs.
• Manage deficiency responses and submission timelines.
• Participate in regulatory meetings such as pre‑submission and dossier compilation.
• Act as the Canadian regulatory lead on global and local project teams.
• Ensure compliance with pharmacovigilance requirements and report safety information to the Teva Pharmacovigilance team.
• Communicate regulatory intelligence and review Health Canada’s evolving guidelines.
• Ensure adherence to Canadian regulations, ICH guidelines, and internal SOPs.
• Monitor...