REGULATORY AFFAIRS MANAGER

ICM PHARMA PTE. LTD.; Singapore; On-site; SGD 50,000 - 80,000; Full time

Job summary

A pharmaceutical company in Singapore is seeking a regulatory affairs professional to ensure compliance with local and international regulations. You will oversee documentation and develop regulatory strategies for new products. Strong experience in regulatory affairs or compliance, along with excellent communication skills, is required for this role.

Qualifications

• Experience in regulatory affairs or compliance roles.
• Strong communication and documentation skills.

Responsibilities

• Formulate regulatory affairs policies to ensure compliance.
• Oversee documentation for local and international standards.
• Develop strategies for product submission.

Job description

• 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.