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 the regulatory landscape and assess impact on development programs and marketed products....