Associate Director, Regulatory Affairs

Job Summary

A company is looking for an Associate Director, Regulatory Affairs CMC and Devices.

Key Responsibilities:

• Plan and coordinate global regulatory submissions, ensuring high-quality, compliant documentation for clinical programs
• Independently author and compile Module 2 and Module 3 content, including technical reports and stability summaries
• Prepare responses to CMC and device-related questions from global regulatory agencies and support health authority interactions

Required Qualifications:

• Bachelor's degree with a minimum of 6+ years of experience in CMC regulatory affairs for clinical-stage biologics
• Hands-on authoring experience for late-stage IND submissions and amendments
• Proven experience preparing responses to health authority questions related to CMC and device topics
• Strong understanding of global CMC regulatory requirements and guidelines
• Experience with biologics and drug-device combination products; familiarity with companion diagnostics is a plus