Senior Manager, Regulatory Affairs

Job Summary

A company is looking for a Senior Manager, Regulatory Affairs.

Key Responsibilities

• Ensure regulatory compliance of products through change control procedures and regulatory impact assessments
• Manage GRA CMC document lifecycles and maintain current regulatory product information for assigned commercial products
• Coordinate the preparation and submission of regulatory compliance documents and support multi-disciplinary teams in establishing Regulatory CMC strategies

Required Qualifications and Education

• BSc/BA with regulatory CMC experience
• Solid understanding of quality management systems and experience with electronic Common Technical Document (eCTD) submissions
• Knowledge of FDA, EMA, and ICH guidelines
• Experience with CMC regulatory documents and the ability to generate clear positions
• Exceptional interpersonal skills to work within multi-disciplinary teams and with external partners