Senior Regulatory Affairs Manager

Job Summary

A company is looking for a Senior Regulatory Affairs Manager.

Key Responsibilities

• Manage regulatory and cross-functional projects, providing strategic and operational support
• Advise project teams on regulatory agency interactions and manage agency communications
• Support the preparation of regulatory submissions and build rapport with clients

Required Qualifications, Training, and Education

• Bachelor's degree in a related field required; advanced scientific degree preferred
• 6 - 8 years of regulatory affairs experience in a clinical research organization or pharmaceutical setting
• Familiarity with manufacturing, specifications, analytical testing, and regulatory CMC requirements
• Thorough knowledge of ICH guidelines and drug development processes
• Proven ability to develop positive client relationships and lead technical teams