California Licensed Regulatory Affairs Manager

Job Summary

Managing regulatory and cross-functional projects, the full-time California Licensed Regulatory Affairs Manager will provide strategic support to clients in regulatory decision-making processes, oversee agency communications, and ensure successful clinical trials and regulatory submissions.

Key responsibilities

• Manage assigned regulatory projects and provide operational support to clients
• Advise project teams on regulatory agency interactions and prepare submissions
• Develop and maintain strong client relationships while translating regulatory requirements into practical applications

Required qualifications

• 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