Join Teva as a Regulatory Affairs Manager in Scarborough, Ontario, and lead regulatory initiatives for generics. This hybrid role emphasizes compliance and strategic planning for successful product launches.
In this position, you will oversee the Canadian regulatory landscape related to new and complex generic medicines. You will develop regulatory strategies, manage submissions to Health Canada, and liaise with both local and global project teams. Your role is crucial in ensuring compliance and addressing regulatory challenges in the biopharmaceutical sector.
Key Responsibilities:
• Coordinate Abbreviated New Drug and supplemental submissions
• Ensure compliance with pharmacovigilance requirements
• Update product labeling materials incorporating safety information
• Lead local teams on global regulatory projects
• Assess impacts of regulatory changes on development
Requirements:
• Bachelor’s in a relevant science field
• Minimum of 5 years in the pharmac...