REGULATORY AFFAIRS MANAGER

2 weeks ago

Singapur, Singapore ICM PHARMA PTE. LTD. Full time

Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced Oversee documentation efforts to ensure compliance with local and international regulations and standards. Develop and maintain standard operating procedures. Develop regulatory strategies and implementation plans for the preparation and submission of new products. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. Review materials such as marketing literature or user manuals to ensure that regulatory requirements are met. Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations. Participate in the development or implementation of clinical trial products. Investigate product complaints and prepare documentation and submissions to appropriate regulatory authorities. Provide responses to regulatory authority regarding product information or issues. Review all regulatory authorities' submission materials to ensure timeliness and accuracy. Communicate regulatory information to relevant departments and ensure that information is interpreted correctly.

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