Regulatory Affairs Manager

Description

• Abbreviated New Drug Submissions (ANDSs)
• Supplemental Abbreviated NDSs (sANDSs)

• Ensure timely updates to product labelling materials, including safety updates to product monographs, associated with regulatory filings
• Manage deficiency responses and timelines of submissions under review
• Participate in regulatory meetings (pre-submission, dossier compilation)
• Act as the Canadian regulatory lead on global and local project teams
• Ensure compliance to the Pharmacovigilance requirements by reporting any safety information to Teva Pharmacovigilance team as per required training
• Communicate regulatory intelligence and review and comment on Health Canada’s evolving guidelines
• Ensure adherence to Canadian regulations, ICH guidelines and internal SOPs
• Monitor regulatory landscape and assess impact on development programs and marketed products.
• Contribute to process improvements and best practices within the Regulatory Affairs function.
• Other Duties as assigned

Qualifications

• Required: Bachelor’s degree in a science‑related field. Preferred: Master’s degree in a science discipline
• 5 years + of experience in the pharmaceutical industry
• Strong background in regulatory strategy and Health Canada submissions
• Experience with sterile products, complex generics, biosimilars, and drug–device combination products
• Proficiency in Microsoft Office applications
• Strong interpersonal skills and the ability to work independently as well as in a team environment
• Leadership skills in managing submissions and projects with multidisciplinary local and global teams
• Knowledge of Health Canada laws and regulations
• Understanding of Health Canada guidances and evolving regulatory initiatives
• Global jurisdictions and ICH knowledge
• Solid scientific and analytical skills
• Working knowledge of Health Canada guidelines
• Priority‑driven, team‑oriented, and goal‑focused approach
• Ability to manage multiple priorities in a matrixed environment