Regulatory Writing Specialist (Clinical)

Senior Regulatory Writing Specialist Clinical & Nonclinical | Pharmaceutical Industry About the Role We are seeking a Regulatory Writing Specialist with at least 3 years of hands-on pharmaceutical regulatory writing experience, particularly in clinical development and regulatory submissions. The successful candidate will have direct authorship experience across multiple regulatory document types, strong document Quality Control (QC) skills, and the ability to manage client-facing projects and deliverables. Experience in nonclinical or preclinical writing, CMC documentation, and regulatory submission preparation would be an advantage. Key Responsibilities Clinical Regulatory Writing: Author and develop Clinical Study Reports (CSRs), clinical study protocols, Investigator's Brochures (IBs), briefing documents, briefing books, and other clinical regulatory documents. Regulatory Submissions: Prepare and support documentation for IND, NDA, BLA, and MAA submissions, including CTD Module 2 documents such as the Clinical Overview (Module 2.5) and Clinical Summary (Module 2.7). Nonclinical & Preclinical Writing: Where applicable, develop nonclinical summaries, overviews, and supporting documentation, including CTD Module 2.4, Module 2.6, and Module 4 documents. Scientific Documentation: Work with clinical evidence reports, scientific source materials, statistical outputs, and, where required, Chemistry, Manufacturing and Controls (CMC) documentation. Document Quality Control: