To obtain a position in the health care industry that will allow me to utilize my skills and experience to provide quality patient care. I am a highly motivated individual with a strong background in the healthcare field.
Collaborate with management and clinical team to develop and implement new product development strategy. Ensure that all regulatory submissions are current and current.
Conduct regulatory review of promotional materials and ensure that all FDA and regulatory requirements are met and are compliant with current regulations and guidelines.
Manage communications with external vendors and partners to ensure timely and accurate responses to regulatory requirements. Review and approve regulatory documents for submission to the FDA.
Serve as a liaison between the clinical research department and the regulatory Affairs department. Ensure that the regulatory documents are in compliance with the FDA and other applicable regulations.
Manage and maintain regulatory documents and regulatory submissions for submission to the FDA. Provide guidance to the project team on the development of the project.
Develop, implement, and maintain the quality assurance and control system (SOPs) for the clinical trial. Perform the development of the regulatory document and ensure compliance with applicable regulations.
Regulatory Affairs Manager
The City University of New York
Liaison with FDA and other regulatory bodies. Ensure that all regulatory submissions are met. And maintain the integrity of the data.
Develop and maintain a tracking system for the regulatory submissions. Ensure that all regulatory documents are submitted to the FDA.
Assist in the development of regulatory documents for submission to the FDA. Review and approve regulatory submissions for submission to the FDA.
Develop and implement new product labeling and packaging systems. Create and maintain regulatory documents. Provide input to Otsuka Canada.
Led the development of a new product development system for the company. This included the creation of a new product line for the market.