Teva Lead Regulatory Affairs Professional 

Croatia, Zagreb 

125467417

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.

• 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

• Relevant 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 7-9 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.

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