Senior Regulatory Affairs Manager

Job Summary

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

Key Responsibilities:

• Plan and coordinate global regulatory submissions, ensuring high-quality documentation for clinical programs
• Independently author and compile CMC-related content, including quality summaries and stability assessments
• Prepare scientifically sound responses to regulatory agency inquiries and support health authority interactions

Required Qualifications:

• Bachelor's degree with 5+ years of experience in CMC regulatory affairs for clinical-stage biologics
• Hands-on experience with late-stage IND submissions and CMC documentation
• Proven ability to prepare responses to health authority questions regarding CMC and device topics
• Strong understanding of global CMC regulatory requirements and guidelines
• Experience with drug-device combination products and familiarity with companion diagnostics is preferred