Director, CMC Regulatory Affairs

📋 Description

• Develop and execute global CMC regulatory strategies for biologics and combo products.
• Lead submissions (INDs/CTAs/IMPDs/BLAs/MAAs) and post-approval filings.
• Prepare regulatory briefing documents and health authority meeting packages.
• Serve as the primary CMC Regulatory lead for cross-functional teams.
• Guide manufacturing processes, analytics, specs, stability, and lifecycle management.
• Monitor evolving global requirements and advise on regulatory trends.

🎯 Requirements

• Bachelor’s degree in Life Sciences or related field.
• 10+ years in Regulatory Affairs, CMC, or related pharma/biotech.
• Significant experience developing global CMC strategies for biologics.
• Strong knowledge of global CMC requirements with INDs/CTAs/BLAs/MAAs.
• Deep knowledge of biologics and combination products incl manufacturing and analytics.
• Experience with health authority interactions and regulatory meetings.

🎁 Benefits

• Salary: $210,000-$235,000 depending on experience.
• Fully remote work with occasional travel.
• Contribute to innovative biologics therapies addressing unmet needs.
• Collaborative, multidisciplinary environment.
• Professional growth in a rapidly advancing biotech.
• Influence global regulatory strategies and product development.