Senior Manager of Regulatory Affairs

Senior Manager of Regulatory Affairs-The Senior Manager of Regulatory Affairs is responsible for ensuring regulatory compliance with relevant regulations and managing submissions to the appropriate regulatory agencies as well as managing junior regulatory affairs staff.

The Senior manager will ensure compliance with relevant regulations, determine risk assessment and implement regulatory strategies for pre-approval, provide regulatory support through product life cycle, manage the preparation of the original application and subsequent regulatory documents and pre and post approval in accordance with agreed timeframes. The Senior Manager will submit applications and negotiate the regulatory approval process for applications with the regulatory agencies. The Senior Manager will participate in R&D meetings to discuss project issues and develop priorities to produce clear project plans with realistic milestones and will provide strategic input for product development and commercialization. The Senior Manager provides regulatory strategy which identifies the required elements necessary for product approval and manages timely receipt of documentation necessary of inclusion in pre-approval reports to the appropriate regulatory agencies. The Senior Manager will develop and maintain a positive working rapport with the regulatory agencies and monitor regulatory agency and industry changes, trends and requirements.

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