Regulatory Affairs Manager planning and coordinating production activities to ensure compliance with regulations and standard operating procedures, while developing strategies for product submissions and representing organizations before regulatory agencies
Experience
Regulatory Affairs Manager
Where you worked
Month Year to Month Year
Developed regulatory strategies and implementation plans for the preparation and submission of new products
Reviewed all regulatory agency submission materials to ensure timeliness, accuracy, and compliance with regulatory standards
Directed the preparation and submission of regulatory agency applications, reports, and correspondence
Investigated product complaints and prepared documentation and submissions to appropriate regulatory agencies as necessary
Provided responses to regulatory agencies regarding product information or issues
Represented organizations before domestic or international regulatory agencies on major policy matters regarding company products
Maintained current knowledge of relevant regulations, including proposed and final rules
Skills
Checking & Planning
Developing procedures, Implementing process changes, Evaluating resources, Examining marketing materials, Reviewing documents for compliance
Core Skills
Monitoring external affairs, Evaluating environmental impact, Monitoring organizational procedures, Monitoring compliance, Managing control system activities