Senior Regulatory Writer – Temporary

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop clear, precise, and compliant documentation needed for regulatory submissions to international health authorities such as the FDA and EMA.

• Compose and refine a diverse array of regulatory documents, including but not limited to: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, and sections of regulatory submission dossiers (e.g., NDA, IND, MAA) such as Module 2 and 5 summary documents (e.g., SCS, SCE, ISS, etc).

• Ensure that all written materials comply with regulatory guidelines, industry standards, and internal quality benchmarks.

• Evaluate intricate scientific and medical information, including clinical trial data, and convert it into clear, concise, and accurate language that is accessible to both technical and non-technical audiences.

• Collaborate closely with cross-functional teams (e.g., clinical research and operations, biostatistics, regulatory affairs, pharmacology, safety, etc.) to guarantee thorough and precise document content.

• Oversee writing projects from inception and coordination to submission, which includes setting timelines and monitoring progress.

• Advise teams on best practices and industry standards, propose solutions to authoring challenges, and facilitate communication and understanding across different functional areas.

⛳️ Requirements

• Bachelor's degree and 7 to 10+ years of relevant industry experience required; an advanced degree in a scientific or medical field is advantageous.

• Proficiency with a majority of common regulatory documents, such as CSRs, IBs, DSURs, protocols, and clinical modules.

• Experience with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), ideally including responses to inquiries, 120-day safety updates, or other post-submission activities.

• Comprehensive understanding of eCTD structure and the clinical development process, along with in-depth knowledge of document-related ICH guidelines and GxPs.

• A minimum of 8 years of experience as a regulatory writer in biotechnology or a related field.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and growth.

• Collaborative and innovative work environment.