Senior Regulatory Writer

Job Summary

To support regulatory submissions, the temporary Senior Regulatory Writer will work remotely, crafting and editing documents for global health authorities while collaborating with cross-functional teams to ensure compliance and accuracy.

Key responsibilities

• Craft clear and compliant regulatory documents for submissions to global health authorities, including FDA and EMA
• Write and edit a variety of regulatory documents such as clinical trial protocols, Investigator Brochures, and Clinical Study Reports
• Manage writing projects from planning to submission, ensuring adherence to timelines and quality standards

Required qualifications

• Bachelor's degree with 7 to 10+ years of industry experience; advanced degree in a scientific or medical field is a plus
• Experience with regulatory documents like Clinical Study Reports, Investigator Brochures, and clinical modules
• Involvement with marketing applications such as INDs, BLAs, NDAs, or MAAs, including post-submission activities
• Expert understanding of eCTD structure and clinical development processes, along with knowledge of ICH guidelines and GxPs
• At least 8 years of experience as a regulatory writer in biotechnology or a related field