Senior Director of Regulatory Writing

Job Summary

A company is looking for a Senior Director, Regulatory Writing.

Key Responsibilities

• Lead the development of regulatory documents for global health authorities, serving as the author for complex submissions
• Author and oversee critical regulatory documents including clinical trial protocols, Investigator Brochures, and regulatory submission dossiers
• Drive continuous improvement in regulatory writing processes and manage end-to-end document development for high-priority programs

Required Qualifications

• Bachelor's Degree in Life Sciences with 18+ years, Master's with 15+ years, or PhD with 13+ years of regulatory writing experience
• Experience with common regulatory documents such as Clinical Study Reports, Investigator Brochures, and clinical modules
• Deep knowledge of eCTD structure, ICH guidelines, and global regulatory requirements
• Involvement with marketing applications, including responses to health authority questions and post-submission activities
• Minimum 10 years as a lead/senior regulatory writer with increasing scope and complexity of assignments