Join Teva Pharmaceuticals as a Regulatory Affairs Manager in Scarborough, Ontario, focusing on compliance and product launches in a hybrid environment. Lead Canadian regulatory strategy and manage key submissions with expertise.
In this hybrid role, you will navigate Abbreviated New Drug Submissions and oversee necessary labelling updates. Your strong background in health regulations will facilitate timely product launches while collaborating with global teams to maintain compliance.
Key Responsibilities:
• Lead the preparation of ANDSs and sANDSs
• Update product labelling materials to meet regulations
• Manage submission timelines and deficiency responses
• Participate in key regulatory meetings effectively
• Serve as the Canadian regulatory lead on project teams
Requirements:
• Bachelor’s degree in a science-related field
• Minimum 5 years in the pharmaceutical industry
• Strong regulatory strategy experience
• Familiarity with complex generics an...