Regulatory Affairs Associate Require at Teva

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.

Post : Regulatory Affairs Associate III

The opportunity
Responsible for leading and managing applications through the regulatory approval process, including preparation of Post Approval Submissions to Health Canada (HC), to obtain timely approvals. Work independently as a professional and keeps management informed of significant regulatory issues that affect assigned products/projects.

Job Description
• Prepare, compile, review and submit high quality submissions for all post approval activities in accordance with Health Canada Regulations and corporate standards.
• Support the development and implementation of regulatory strategies for defined projects until approval and launch as applicable.
• Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner
• Responsible for evaluating change controls for regulatory filing assessments in accordance with HC guidance documents. Subsequently prepare and ensure all timely post approval regulatory activities, as applicable.
• Keep current with the Teva work procedures, Health Canada Regulations/ Guidance as well as ICH regulations
• Business development assessments as applicable
• Other projects and duties as required/assigned

Candidate Profile
• M.Pharma degree in a scientific discipline
• Minimum 5-7 years in Regulatory affairs in post approval (EU/FDA with preference for HC) and overall pharma experience of 7-10 years
• Preferred, experience with sterile products.
• Excellent oral and written communication
• Excellent organizational skills and the ability to multi-task; detail oriented.
• Possesses strong critical and logical thinking

Additional Information
Job Id : 63515
Experience : 5-7 years
Qualification : M.Pharma degree
Location : Bangalore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 31st August 2025