REGULATORY AFFAIRS MANAGER
ICM PHARMA PTE. LTD.
- 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.
JOB SUMMARY
REGULATORY AFFAIRS MANAGER
ICM PHARMA PTE. LTD.
Singapore
10 days ago
N/A
Full-time
REGULATORY AFFAIRS MANAGER