Job Description
Lead regulatory strategy for Teva Pharmaceuticals as a Regulatory Affairs Manager in Scarborough, Ontario, focusing on submissions and compliance within a hybrid work setting. Drive product launches while maintaining adherence to evolving regulations.
In this role, you will prepare Abbreviated New Drug Submissions and manage labelling updates with precision. Collaborating with global teams, your insights into health regulations will ensure a smooth product launch process.
Key Responsibilities:
• Oversee preparation and submission of ANDSs and sANDSs
• Update labelling materials for regulatory compliance
• Manage timelines and responses to deficiencies
• Participate actively in critical regulatory meetings
• Act as the Canadian regulatory lead on projects
Requirements:
• Bachelor’s degree in a science-related discipline
• Over 5 years in the pharmaceutical sector
• Proven background in regulatory strategy
• Experience with complex generics and biosimi...
In this role, you will prepare Abbreviated New Drug Submissions and manage labelling updates with precision. Collaborating with global teams, your insights into health regulations will ensure a smooth product launch process.
Key Responsibilities:
• Oversee preparation and submission of ANDSs and sANDSs
• Update labelling materials for regulatory compliance
• Manage timelines and responses to deficiencies
• Participate actively in critical regulatory meetings
• Act as the Canadian regulatory lead on projects
Requirements:
• Bachelor’s degree in a science-related discipline
• Over 5 years in the pharmaceutical sector
• Proven background in regulatory strategy
• Experience with complex generics and biosimi...